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Biofrontera AG: Conference call to discuss half-year 2021 financial results to be held on August 20, 2021

On August 12, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported that it will be releasing its financial results for the first six months ended June 30, 2021 on Thursday, August 19, 2021 (Press release, Biofrontera, AUG 12, 2021, View Source [SID1234586417]).

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

BioLineRx to Report Second Quarter 2021 Results on August 18, 2021

On August 12, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported it will release its unaudited financial results for the quarter ended June 30, 2021 on Wednesday, August 18, 2021, before the US markets open (Press release, BioLineRx, AUG 12, 2021, View Source [SID1234586416]).

The Company will host a conference call on Wednesday, August 18, 2021 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-866-744-5399 from the U.S. or +972-3-918-0644 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until August 20, 2021; please dial +1-888-295-2634 from the U.S. or +972-3-925-5904 internationally.

Exicure, Inc. Reports Second Quarter 2021 Financial Results and Corporate Progress

On August 12, 2021 Exicure, Inc. (NASDAQ:XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported financial results for the quarter ended June 30, 2021 and provided an update on corporate progress (Press release, Exicure, AUG 12, 2021, View Source [SID1234586415]).

"We continue to drive towards a number of key value inflection points across our platforms and programs," commented Dr. David Giljohann, Exicure’s Chief Executive Officer. "Notably, we believe our momentum in neurology is particularly strong on the heels of our recently announced collaboration with Ipsen for Huntington’s disease and Angelman syndrome. Our team has also made impressive progress in our preclinical neurology pipeline, with a planned IND filing in Friedreich’s ataxia and work in pain and Batten disease using our SNA technology."

Pipeline Highlights & Updates

Neurology

Ipsen Collaboration

On August 2, 2021, IPSEN BIOPHARM LIMITED (Ipsen) and Exicure announced an exclusive collaboration agreement to research, develop, and commercialize novel SNAs as potential investigational treatments for Huntington’s disease (HD) and Angelman syndrome (AS). Under the terms of the collaboration:
Ipsen obtains two exclusive options to SNAs currently under discovery evaluation for HD and AS;
Exicure will be responsible for discovery and certain preclinical development activities. In the event Ipsen exercises an option with respect to the two collaboration programs, Ipsen will be responsible for further development and worldwide commercialization for the corresponding licensed product;
Exicure received a $20 million upfront payment and is eligible to receive up to $1 billion in option exercise fees and milestone payments should Ipsen opt into both programs, as well as tiered royalties.
XCUR-FXN – Friedreich’s Ataxia

The Company hosted a virtual R&D Day on July 15, 2021 to present new and previously unreleased preclinical data and discuss progress with XCUR-FXN:
Observed 2-3x fold change in measurable Frataxin protein in the cerebellum and dorsal root ganglia (amongst other important brain and spinal regions) in Pook800J mouse model indicating potential for disease resolution;
Showed no adverse, test-related histopathological findings in repeat dose range finding rat study.
The Company continues to expect to file for an IND for XCUR-FXN in FA by the end of 2021 and to dose the first human patient in the first half of 2022.
SCN9A – Neuropathic Pain

Presented supporting data for targeting the SCN9A gene which encodes for the NaV1.7 sodium channel, a sought after, but difficult to drug target with highly selective SNA approach.
CLN3 – Batten Disease

Generated in vivo Proof of Concept data of an SNA splice switching mechanisms to correct mutations in the CLN3 gene and upregulate CLN3 mRNA in the retinae of Batten disease mice.
Immuno-Oncology

Cavrotolimod (AST-008)

The Phase 1b/2 clinical trial of intra-tumoral cavrotolimod in combination with approved checkpoint inhibitors pembrolizumab or cemiplimab, for the treatment of patients with advanced or metastatic Merkel cell carcinoma (MCC) or cutaneous squamous cell carcinoma (CSCC), is open and actively enrolling patients:
As of August 4, 2021, total trial enrollment for the Phase 1b/2 trial including primary and exploratory cohorts was 51 patients.
Interim results from the Phase 2 portion of the clinical trial were reported on August 5, 2021 on 26 patients, 17 of whom were evaluable.
A complete response (CR) in one MCC patient met the pre-specified Phase 2 stage threshold to continue advancing patient enrollment in the MCC cohort;
Injected and non-injected tumor lesions completely resolved in the MCC patient with a CR, supporting systemic (abscopal) effects;
Eight evaluable patients were enrolled across either the CSCC dose-expansion cohort, in which enrollment and data accrual is continuing, or exploratory cohort;
The confirmed overall response rate (ORR) in all evaluable MCC patients enrolled in total in the Phase 1b/2 study was 21% (3 of 14) as of the July 1, 2021 data cutoff date, comprised of two CRs and one partial response (PR);
The Company expects to provide ORR results from the Phase 2 portion of the trial in the first half of 2022.
Corporate Updates

Expanded the executive management team with the appointments of Brian C. Bock as Chief Financial Officer and Elias D. Papadimas as Chief Accounting Officer.
First Quarter Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents, short-term investments, and restricted cash were $57.3 million as of June 30, 2021 compared to $68.6 million as of March 31, 2021.

Research and Development (R&D) Expenses: R&D expenses were $10.8 million for the quarter ended June 30, 2021, compared to $7.0 million for the quarter ended June 30, 2020. The Company has increased full-time headcount in R&D from 41 at June 30, 2020 to 66 at June 30, 2021. The increase in R&D expense reflects this increased headcount and the related increase in R&D activities, in addition to increased clinical trial activities.

General and Administrative Expenses: General and administrative expenses were $3.1 million for the quarter ended June 30, 2021, compared to $2.2 million for the quarter ended June 30, 2020. This increase is primarily due to costs related to new hires needed to grow the Company as it evolves.

Net Loss: Exicure had a net loss of $14.3 million for the quarter ended June 30, 2021 compared to net loss of $4.3 million for the quarter ended June 30, 2020. The increase in net loss was primarily driven by lower revenue associated with Exicure’s collaboration with AbbVie as well as higher R&D costs to advance our pipeline and higher G&A costs associated with an increase in headcount.

Cash Runway Guidance: The Company believes that, based on its current operating plans and estimates of future expenses, as of the date of this press release, its existing cash, cash equivalents and short-term investments, including the $20 million upfront payment received relating to the Company’s announced partnership with Ipsen subsequent to June 30, 2021, will be sufficient to fund its operations for at least the next 12 months.

Evaxion Biotech Announces Q2 2021 Financial Results and Provides Business Update

On August 12, 2021 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, reported the second quarter 2021 financial results and provided an operational update (Press release, Evaxion Biotech, AUG 12, 2021, View Source [SID1234586414]).

Lars Wegner, CEO of Evaxion, said: "Evaxion has made very encouraging clinical progress in the second quarter of 2021, reporting data in July which we believe support advancing both of our lead programs into Phase 2b trials. Phase 1/2a data on our lead program EVX-01 showed that 67% of the patients benefited from EVX-01 in combination with anti-PD-1 for the treatment of metastatic melanoma, compared to the historical data of only 40% benefiting from the check point inhibitor alone. In addition, EVX-02 showed T-cell activation in adjuvant melanoma and appeared to be well tolerated. We plan to initiate a Phase 2b trial for EVX-01 in melanoma in December 2021 and initiate a Phase 2b trial of EVX-02, in conjunction with our third program, EVX-03, in Q2 2022. We also reported preclinical proof of concept data for our RAVEN AI platform for vaccine design and development for viral infections, which we believe has the potential to make a significant contribution in addressing coronavirus infections and other viral diseases. Our cash reserves of $18.8 million provide a solid financial foundation and will facilitate the continued development of these four lead programs."

Operational and Business Highlights in Q2 2021

Reported preclinical proof of concept data in June for the Adaptive and Intelligent Vaccine for a Rapid Response against Corona Viruses (AICoV) program, supporting next-generation coronavirus vaccine technology. First-generation SARS-COV-2 vaccines are focused on the generation of neutralizing antibodies by B cells that bind to the spike protein of the virus and inhibit infection. Activation of T cells may help broaden the immune system’s response to coronavirus and protect against mutations on the spike protein that have been shown to circumvent immunity. Early data demonstrate our RAVEN platform identifies novel immunogenic T-cell epitopes beyond just the spike protein. The proof-of-concept data show RAVEN’s potential to rapidly support the design of novel SARS-COV-2 vaccines capable of tackling newly emerging coronavirus variants.
EVX-03, a novel patient-specific therapy for multiple cancer indications and EVX-B1, a vaccine for the prevention of Staphylococcus aureus including MRSA, continue to progress as expected through preclinical and Chemistry, Manufacturing and Controls (CMC) development.
Presentation in April at the 4th Neoantigen Summit Europe, described Evaxion’s recent improvement in determining cancer neoepitopes through measurement and prediction of peptide-MHC (pMHC) complex stability. We believe this is a significant improvement over AI models trained on traditional mass spectrometry ligand data and the data have already proven valuable in improving our discovery and design of patient-specific neoepitopes used to derive our cancer therapies.
Acceptance of a scientific paper by the International Conference on Machine Learning describing a novel predictive system based on deep probabilistic programming that enables the rapid conversion of sequence data into structural information on protein fragments, which we believe may be useful for drug and vaccine design.
Events after the Reporting Period

Reported new clinical data in early July from Phase 1/2a trials of EVX-01 and EVX-02.
EVX-01, our peptide-based patient-specific cancer therapy, demonstrated anti-tumor effect in combination with anti-PD-1 treatment, a checkpoint inhibitor anticancer drug, for metastatic melanoma. Results from the combination therapy compares favorably to historical data from anti-PD-1 treatment alone. A Phase 2b trial of EVX-01 is planned to start in December 2021.
Preliminary data with EVX-02, our DNA-based patient-specific cancer therapy, demonstrated T-cell activation induced by EVX-02 and appeared to be well tolerated. A Phase 2b trial of EVX-02, in combination with EVX-03, our novel patient-specific therapy for multiple cancer indications, is planned to start in Q2 2022 as a combination therapy with anti-PD-1 in adjuvant melanoma.
Expected milestones in 2021 & 2022

Phase 2b trial initiation of EVX-01 in metastatic melanoma – Q4 2021.
Phase 2b trial regulatory filing for EVX-02 in combination with EVX-03 in adjuvant melanoma – Q2 2022.
Phase 1a trial regulatory filing for EVX-B1 for S. aureus in skin and soft tissue infections (SSTIs) – H2 2022.
First viral candidate selected from RAVEN platform – Q1 2022.
Second Quarter 2021 Financial Results

Cash position: As of June 30, 2021, cash and cash equivalents were $18.8 million compared to $5.8 million as of December 31, 2020. On February 9, 2021, we closed our IPO raising net proceeds of $27.9 million after underwriting discounts and commissions, but before offering expenses.
Research and Development expenses were $5.1 million for the quarter ended June 30, 2021, compared to $2.6 million for the same period in 2020. The increase of $2.5 million was primarily related to increased spending, net of grant income, for ongoing development utilizing our AI platforms, preclinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount.
General and Administrative expenses were $1.9 million for the quarter ended June 30, 2021, compared to $1.4 million for the same period in 2020. The increase of $0.5 million was primarily related to increases in overhead and professional fees related to the expansion of our corporate function.
Net loss was $6.8 million for the quarter ended June 30, 2021 or ($0.36) loss per basic and diluted share, compared to $3.6 million, or ($0.24) loss per basic and diluted share, for the same period in 2020.
Guidance

Evaxion’s current cash position of $18.8 million is expected to be sufficient to fund key clinical programs into 2022.
Webcast and Conference Call

Alternatively to access the audio webcast, please visit the events page of Evaxion’s website at:

View Source

Selecta Biosciences Reports Second Quarter 2021 Financial Results and Provides Business Update

On August 12, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported financial results for the second quarter ended June 30, 2021 and provided a business update (Press release, Selecta Biosciences, AUG 12, 2021, View Source [SID1234586413]).

"We are very pleased about our continued progress across all aspects of the company," said Carsten Brunn, Ph.D., president, and chief executive officer of Selecta. "Building on our ongoing empty AAV8 capsid study, we are rapidly advancing our two proprietary gene therapy programs into the clinic and as we enter a critical inflection point in development, we are honored to have gene therapy pioneer, Jude Samulski, Ph.D., join as a special advisor. The recently published preclinical data is encouraging and further supports the advancement of our lead candidate in methylmalonic acidemia (MMA), SEL-302. We will build on this momentum and expect to file an IND in MMA during the third quarter of 2021, bringing us one step closer to addressing immunogenicity constraints in AAV-driven gene therapy and ultimately, providing patients with potentially transformative treatment options. Additionally, we are steadily executing across our enzyme and autoimmune development program. We have a well-defined work plan ahead of us and the financial resources to maximize the value of our innovative ImmTOR platform."

Recent Highlights and Anticipated Upcoming Milestones:

Enzyme Therapies:

SEL-212 for chronic refractory gout: Enrollment for the Phase 3 DISSOLVE clinical program for the treatment of chronic refractory gout, which was licensed to Sobi, is progressing as planned.
Topline data is expected in the second half of 2022.
Investigational New Drug, or IND, enabling studies are underway for a novel therapeutic approach that combines ImmTOR with an enzyme, IgA1 protease for the treatment of IgA nephropathy.
Selecta expects to file an IND in IgA nephropathy in 2022 and will provide additional updates later in the year.
Gene Therapies:

First-in-human trial of SEL-399: In collaboration with AskBio, Selecta initiated the first-in-human, dose-escalation trial of SEL-399, an adeno-associated viral serotype 8 (AAV8) empty vector capsid (EMC-101) containing no DNA combined with ImmTOR. The trial aims to determine the dose regimen of ImmTOR to mitigate the formation of antibodies to AAV8 capsids used in gene therapies.
Topline data is expected in the fourth quarter of 2021.
SEL-302 for methylmalonic acidemia (MMA): Selecta announced publication in the journal Molecular Therapy Methods & Clinical Development demonstrating that ImmTOR enhances transgene expression after both initial and repeat dosing of AAV in a mouse model of MMA. The publication further validates use of ImmTOR in Selecta’s gene therapy pipeline, including its lead candidate, SEL-302 (MMA-101 in combination with ImmTOR), for the treatment of MMA, a rare metabolic disease in which the body cannot break down certain proteins and fats.
The previously disclosed MMA-101 manufacturing issue was resolved. Manufacturing of a new lot has been completed and is currently undergoing final release testing.
Selecta expects to file an IND for SEL-302 during the third quarter of 2021.
SEL-313 for ornithine transcarbamylase deficiency (OTC deficiency): Selecta’s proprietary gene therapy product candidate, SEL-313, is being developed to treat OTC deficiency, a rare genetic urea cycle disorder that causes ammonia to accumulate in the blood due to mutations in the OTC gene.
SEL-313 is currently in preclinical development and a clinical trial application, or CTA and/or IND filing are expected in 2022.
Sarepta Therapeutics program in Duchenne Muscular Dystrophy (DMD) and certain Limb-Girdle Muscular Dystrophies (LGMD) subtypes: Selecta has achieved a $3 million milestone payment related to the completion of a preclinical study under the Research License and Option Agreement.
Restoring Self-Tolerance in Autoimmune Diseases:

Selecta announced Frontiers in Immunology publication showcasing the enhanced hepatic tolerogenic potential of ImmTOR. Data demonstrate that ImmTOR enhances the tolerogenic environment in the liver, shows induction of a tolerogenic phenotype in all major hepatic antigen presenting cell populations and is protective in an acute model of autoimmune hepatitis. The publication further supports development of Selecta’s ImmTOR platform for the treatment of liver-specific autoimmune diseases, including primary biliary cholangitis (PBC).
Selecta continues IND-enabling work on an ImmTOR-based approach to treating PBC and expects to file an IND in PBC in the second half of 2022.
Corporate Updates:

Jude Samulski, Ph.D., was appointed as a special advisor to help guide Selecta’s gene therapy programs into the clinic. Dr. Samulski is a professor of pharmacology and has been the director of the University of North Carolina Gene Therapy Center for over two decades. He was awarded the first patent for AAV as a viral vector and was the first recipient of the American Society of Gene & Cell Therapy Outstanding Achievement Award for lifetime achievements in gene therapy. Dr. Samulski has advanced gene therapies into human clinical trials for hemophilia, Duchenne muscular dystrophy, giant axonal neuropathy, Pompe disease and heart failure, and is the president, chief scientific officer and co-founder of Asklepios BioPharmaceutical Inc. (AskBio), a biotechnology company focused on AAV-driven gene therapy.

Nishan de Silva, M.D. was appointed to Selecta’s Board of Directors. Dr. de Silva has extensive leadership experience, most relevantly in gene therapy development, manufacturing, and regulatory activities. Dr. de Silva brings over 20 years of experience in biotechnology operations, biopharmaceutical venture capital and healthcare management consulting. He is currently chief executive officer and director of AFYX Therapeutics, a private venture-backed biotechnology company focused on addressing unmet needs in mucosal diseases. Previously Dr. de Silva served as president, chief operating officer and director of Poseida Therapeutics, a cell and gene therapy-focused biopharmaceutical company, where he oversaw clinical development, regulatory, manufacturing, finance, and business development activities.
Second Quarter 2021 Financial Results:

Cash Position: Selecta had $151.5 million in cash, cash equivalents, marketable securities, and restricted cash as of June 30, 2021, which compares to cash, cash equivalents, and restricted cash of $149.2 million as of March 31, 2021. Selecta believes its available cash, cash equivalents, marketable securities, and restricted cash will be sufficient to meet its operating requirements into the third quarter of 2023.

Net cash used in operating activities was $18.2 million for the six months ended June 30, 2021, as compared to $23.5 million for the same period in 2020.
Revenue: Revenue recognition for the second quarter of 2021 was $19.7 million, compared to no revenue recognition for the same period in 2020. Revenue was recognized under the license agreement with Sobi which began in July 2020 resulting from the shipment of clinical supply and the reimbursement of costs incurred for the Phase 3 DISSOLVE clinical program. Additionally, during the second quarter, Selecta recognized less than $0.1 million for shipments under the license agreement with Sarepta and $0.1 million resulting from the expiration of the contractual audit term under the Skolkovo Foundation grant.

Research and Development Expenses: Research and development expenses for the second quarter 2021 were $14.5 million, which compares with $10.7 million for the same period in 2020. During the quarter ended June 30, 2021, there was an increase in expenses incurred for consulting, salaries, and the discovery and preclinical programs, offset by a decrease of AskBio collaboration costs.

General and Administrative Expenses: General and administrative expenses for the second quarter 2021 were $4.7 million, which compares with $5.6 million for the same period in 2020. The decrease in costs was primarily the result of reduced expense for salaries, professional fees and patent expense, offset by increased consulting and stock compensation expenses.

Net Income (loss): For the second quarter 2021, Selecta reported net income of $4.6 million, or basic net income per share of $0.04, compared to a net loss of $24.1 million, or basic net loss per share of $0.25 for the same period in 2020.

Conference Call and Webcast Reminder:
Selecta management will host a conference call at 8:30 AM ET today to provide a corporate update and review the company’s second quarter 2021 financial results. Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10147802. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.