On August 11, 2020 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three and six months ended June 30, 2020 and provided a business update (Press release, Altimmune, AUG 11, 2020, View Source [SID1234563521]).

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"We are pleased with Altimmune’s progress during 2020 as we have launched two new product candidates for COVID-19, progressed our NASH candidate toward clinical testing and forged strategic alliances with Vigene Biosciences and DynPort Vaccine Company" said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "With the support of our shareholders, we now have more than $200 million of cash and investments on hand to drive continued development of our product pipeline."

Recent Highlights

Received gross proceeds of $199.4 million from a public offering, warrant exercises and ATM sales since Q1 2020
Since the first quarter, the Company has received $132.2 million in gross proceeds from a public offering of common stock and pre-funded warrants, $40.9 million from warrant exercises and $26.3 million in gross proceeds from ATM sales. The cash received will be used primarily for the development of AdCOVID and T-COVID, including scale up of manufacturing and advanced clinical trials; the continued development of ALT-801, a dual GLP-1/glucagon receptor agonist for the treatment of non-alcoholic steatohepatitis (NASH), including the first-in-human trial later this year; and for capital expenditures and general working capital purposes.

Announced positive preclinical results for AdCOVID
The Company announced positive results from the preclinical studies of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. The studies, which were conducted in collaboration with the University of Alabama at Birmingham (UAB), showed strong serum neutralizing activity and potent mucosal immunity in the respiratory tract. The induction of mucosal IgA antibody in the respiratory tract may be necessary to block both infection and transmission of the virus to prevent further spread of COVID-19. Based on these findings, the Company has initiated manufacturing of AdCOVID and plans to advance the vaccine candidate to a Phase 1 safety and immunogenicity study in Q4 of this year.

Announced manufacturing agreement with Vigene Biosciences for AdCOVID
The Company announced that it has entered into an agreement with Vigene Biosciences to manufacture AdCOVID, the Company’s single-dose intranasal vaccine candidate for COVID-19. Vigene, a Rockville, Maryland-based award-winning Contract Development and Manufacturing Organization, specializes in viral vectors and will deploy its capabilities to manufacture AdCOVID. Following recent positive pre-clinical data, the Company plans to start a Phase 1 clinical trial of AdCOVID in Q4 2020.

Formed teaming agreement with DynPort Vaccine Company for AdCOVID
The Company announced that it has entered into a teaming agreement with DynPort Vaccine Company (DVC), a General Dynamics Information Technology (GDIT) company, to coordinate U.S. Government funding efforts and, if successful, to provide program management, drug development activity integration, and regulatory support for AdCOVID.

Initiated T-COVID program and received $4.7 million award from the DoD to fund Phase 1/2 clinical trial
The U.S. Food and Drug Administration (FDA) authorized the Company to proceed with a Phase 1/2 clinical trial of T-COVID, an investigational therapeutic agent for the treatment of early COVID-19. The EPIC Trial (Efficacy and Safety of T-COVID in the Prevention of Clinical Worsening in COVID-19) is being funded through a $4.7 million competitive award from the U.S. Army Medical Research & Development Command (USAMRDC) and Department of Defense (DoD) working in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium. Altimmune recently initiated multiple clinical sites across the United States and expects that enrollment will commence imminently.

Completed enrollment in Phase 1b clinical trial of NasoShield
The Company completed enrollment in its Phase 1b clinical trial of NasoShield, a single dose intranasal anthrax vaccine candidate. The NasoShield program is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA), with a total potential value of $133.7 million if all options in the contract (HHSO100201600008C) are exercised. At the conclusion of the Phase 1b NasoShield trial, BARDA will have the option of exercising the remaining contract options valued at approximately $105 million to enable Phase 2 development.

Advanced IND-enabling activities for ALT-801 GLP-1/glucagon dual receptor agonist for NASH
The Company has successfully completed the in-life portion of the safety and toxicological assessment of ALT-801 and is manufacturing the clinical trial material for the first-in-human trial, expected to start in Q4 2020. The single and multiple ascending dose trial will be conducted in Australia and will evaluate the safety and activity of ALT-801 in overweight and obese volunteers. Data from that study, including validation of the compound’s weight loss and liver fat-reducing effects, is expected to read out in the spring of 2021.

Received HepTcell IND clearance for Phase 2 trial
The FDA cleared the Company’s Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B (HBV). The Company is also filing CTAs in Canada and three European countries. Altimmune plans to initiate the multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct.
Financial Results for the Second Quarter Ended June 30, 2020

The Company had cash, cash equivalents and short-term investments of $80.3 million at June 30, 2020. Subsequent to the quarter ended June 30, 2020, the Company received approximately $136.2 million in net proceeds from the public offering of its common stock, warrant exercises, and ATM sales.
Revenue was $0.7 million for the quarter ended June 30, 2020 compared to $1.6 million in the prior year period. The change was primarily due to a decrease in billings under the Company’s U.S. government contracts due to timing of manufacturing and clinical trials for the NasoShield program.
Research and development expenses were $16.5 million for the quarter ended June 30, 2020 compared to $2.9 million in the prior year period. The increase was primarily attributable to an increase in the contingent liability for stock-based milestone payments associated with the acquisition of ALT-801; development costs for IND-enabling preclinical studies for ALT-801; and development costs for the COVID-19 programs. These increases were partially offset by decreased spend on the NasoShield program.
General and administrative expenses were $2.5 million for the quarter ended June 30, 2020 compared to $2.2 million in the prior year period. The increase is attributable to higher employee compensation and legal costs.
Income tax benefit was $1.6 million for the three months ended June 30, 2020, as compared to zero for the same period in 2019. The increase is attributable to the Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act") passed on March 27, 2020 which made temporary changes regarding the utilization and carry back of net operating losses. The Company intends to file a tax refund claim with the Internal Revenue Service reflecting a partial refund of its 2016 tax liability by carrying back net operating losses arising during the three and six months ended June 30, 2020.
Net loss attributed to common stockholders for the quarter ended June 30, 2020 was $16.8 million, or $0.94 net loss per share, compared to $3.4 million in the prior year, or $0.26 net loss per share. The difference in net loss is primarily attributable to higher research and development expenses, lower revenue, offset by an increase in income tax benefit.
Conference Call Information

Altimmune will host a conference call to discuss the company’s second quarter results and other business information.
Date: Wednesday, August 12, 2020
Time: 8:30 am Eastern Time
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13706947
Webcast: View Source
Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The company has used, and intends to continue to use, the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

On August 11, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (Aurinia or the Company) reported financial results for the second quarter ended June 30, 2020 and provided an update on recent operational highlights (Press release, Aurinia Pharmaceuticals, AUG 11, 2020, View Source [SID1234563520]).

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"The acceptance of the voclosporin NDA is a significant step towards our goal of delivering the first FDA-approved therapy specifically for people living with lupus nephritis," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "These people suffer from a debilitating, progressive condition that, if not adequately or quickly controlled, leads to life-threatening end-stage renal disease. Despite its high healthcare burden, lupus nephritis has no approved treatments in the United States which we believe has contributed to low awareness of this condition. Aurinia feels the urgency of its mission to change the course of lupus nephritis for this community in need, by combining deep engagement and advocacy efforts with truly innovative medical science."

In addition to preparing for the launch of voclosporin for use as a potential treatment for lupus nephritis (LN), Aurinia continues to explore voclosporin in other proteinuric kidney indications and expects to provide an update on a planned clinical development program later this year. The Company’s development of voclosporin ophthalmic solution (VOS) for dry eye syndrome (DES) remains on track to report topline results from its Phase 2/3 AUDREYTM dose-ranging trial during the fourth quarter of 2020.

Max Colao, Chief Commercial Officer of Aurinia, commented, "As we make progress on our regulatory submission, we’re rapidly building a world class commercial team that is fully resourced and committed to engaging the lupus nephritis community and healthcare professionals. Our strategy for a successful U.S. launch will be executed by deeply experienced Aurinia specialists and led by a proven leadership team. We are driven to make a difference in the lives of the lupus nephritis patients and our team will be launch ready in advance of our PDUFA date of January 22, 2021."

Second Quarter 2020 Highlights

New Drug Application for voclosporin granted Priority Review and January 22, 2021 PDUFA date

In July 2020 the Company announced that the U.S. Food & Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin, as a potential treatment for LN. The FDA has granted Priority Review for the NDA, which provides an expedited six-month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021. The FDA has also informed the Company that they are not currently planning to hold an advisory committee meeting to discuss the application. The FDA has the option to change this decision based on review of the pending NDA. There are currently no FDA-approved treatments for LN.

Further supportive data from AURORA pivotal study presented at scientific conferences

The Company presented additional safety data and subgroup analyses from the completed AURORA pivotal trial of voclosporin at two scientific meetings during the quarter: the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 2020 Virtual Congress and the European League Against Rheumatism (EULAR) 2020 E-Congress. The data further supported the safety profile of voclosporin on an additional measure of kidney function and its clinically meaningful benefits for trial participants across ethnicities and self-reported race. These data were notable for further adding to the evidence supporting voclosporin’s benefit over the standard-of-care with no apparent safety penalty, and its potential to deliver equal clinical benefits for patients of ethnicities or self-reported races disproportionately affected by lupus nephritis.

Phase 2/3 AUDREY Phase 2/3 Clinical Trial of VOS

In June 2020, Aurinia announced it had completed enrollment for the Phase 2/3 AUDREYTM clinical trial evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of DES, a chronic disease estimated to affect more than 16 million people in the United States.

The AUDREYTM trial is a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of 509 subjects have been enrolled and randomized into one of four arms with a 1:1:1:1 randomization schedule, in which patients receive either VOS 0.2%, VOS 0.1%, VOS 0.05% or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial is the proportion of subjects with a 10mm or greater improvement in the Schirmer Tear Test (STT) at four weeks. Secondary outcome measures will include STT at other time points, Fluorescein Corneal Staining (FCS) at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints. AUDREYTM builds on positive exploratory Phase 2 results demonstrating that 0.2% VOS administered twice daily was superior to cyclosporin A 0.05% (Restasis) administered twice daily across all objective endpoints. Top-line results from the AUDREYTM clinical study are anticipated during the fourth quarter of 2020.

Recent Director and Officer Appointments

Appointment of Timothy P. Walbert to the Board

On April 20, 2020, Aurinia announced the appointment of Mr. Walbert to the Board of Directors. Mr. Walbert has nearly 30 years of experience commercializing pharmaceutical products. Mr. Walbert is currently Chairman, President and Chief Executive Officer of Horizon Therapeutics plc. He also served as President, Chief Executive Officer and Director of IDM Pharma, Inc., a public biopharmaceutical company which was acquired by Takeda.

Appointment of Joe Miller as Chief Financial Officer

On April 27, Aurinia appointed Mr. Miller as Chief Financial Officer following the retirement of Mr. Dennis Bourgeault, who served in that role since 1998. Mr. Miller will be responsible for developing and leading the Company’s financial operations to effectively support the Company’s rapid growth.

Financial Liquidity at June 30, 2020 and July Public Offering of Common Shares

All amounts in this press release, unless specified otherwise, are expressed in U.S. dollars.

As of June 30, 2020, Aurinia had cash, cash equivalents and short-term investments of $264.4 million compared to $286.1 million at March 31, 2020 and $306 million at December 31, 2019. Net cash used in operating activities was $22.6 million for the second quarter ended June 30, 2020 compared to $13.3 million for the second quarter ended June 30, 2019.

Following the recently completed $200 million public offering, which closed on July 27, 2020, the Company’s cash, cash equivalents and short term investments totaled approximately $442.06 million at July 31, 2020. The Company believes that it has sufficient financial resources to fund its current plans, which include conducting its ongoing research and development (R&D) programs, completing the NDA submission to the FDA, conducting pre-commercial and launch activities, manufacturing and packaging commercial drug supply required for launch, and fund its supporting corporate and working capital needs through the end of 2022.

Financial Results for Three Months Ended June 30, 2020

The Company reported a consolidated net loss of $29.5 million or $0.26 per Common Share for the second quarter ended June 30, 2020, as compared to a consolidated net loss of $15.9 million or $0.17 per Common Share for the second quarter ended June 30, 2019.

The loss for the second quarter ended June 30, 2020 reflected an increase of $3.0 million in the estimated fair value of derivative warrant liabilities compared to a reduction of $625,000 in the estimated fair value of derivative warrant liabilities for the second quarter ended June 30, 2019. The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by the Company. The outstanding warrants expire on December 28, 2021.

The loss before the change in estimated fair value of derivative warrant liabilities and income taxes was $26.6 million for the second quarter ended June 30, 2020 compared to $16.5 million for the same period in 2019.

R&D expenses decreased to $11.1 million for the second quarter ended June 30, 2020 compared to $11.2 million for the second quarter ended June 30, 2019. The decrease in these expenses primarily reflected higher costs related to the preparation of the NDA submission and related supporting activities, the ongoing VOS Phase 2/3 AUDREYTM trial, the AURORA 2 extension trial and the expansion of the medical affairs team to support the launch of voclosporin partially offset by lower AURORA trial costs as this trial is now complete. Non-cash stock compensation expense charged to R&D also increased to $1.1 million for the second quarter ended June 30, 2020 compared to $749,000 for the comparable period in 2019 reflecting the hiring of a significant number of personnel in 2020 and an increase in the fair value of the stock options granted due to the increase in the Company’s share price.

Corporate, administration and business development expenses increased to $15.5 million for the second quarter of 2020 compared to $4.9 million for the second quarter of 2019. These expenses included the expansion of the commercial team, higher consulting and professional fees, insurance costs, and personnel compensation costs as the corporate organization buildout continued in the second quarter of 2020. Non-cash stock compensation expense charged to corporate, administration and business development also increased to $3.1 million for the second quarter ended June 30, 2020 compared to $1.2 million for the comparable period in 2019 reflecting the hiring of a significant number of personnel in 2020 and an increase in the fair value of the stock options granted due to the increase in the Company’s share price.

Financial Results for Six Months Ended June 30, 2020

For the six months ended June 30, 2020, Aurinia reported a consolidated net loss of $46.1 million or $0.41 per Common Share compared to a consolidated net loss of $28.3 million or $0.31 per common share for the comparable period in 2019.

R&D expenses were $24.9 million for the six months ended June 30, 2020 compared to $21.8 million for the same period in 2019. The increase in these expenses reflected higher costs incurred for the AURORA 2 extension trial, and preparation costs associated with the LN NDA submission partially offset by lower AURORA trial costs as this trial is now complete.

Corporate, administration and business development expenses were $26.6 million for the six months ended June 30, 2020 compared to $8.8 million for the same period in 2019. The increase reflects the same items as noted in the second quarter corporate, administration and business development expenses.

Non-cash stock compensation expense totaled $7.7 million for the six months ended June 30, 2020 as compared with $3.6 million for the same period in 2019 and is included in both research and development and corporate, general and business development expenses.

For the six months ended June 30, 2020 Aurinia recorded a decrease of $6.9 million in the estimated fair value of derivative warrant liabilities compared to a decrease of $2.4 million for the comparable period in 2019.

This press release should be read in conjunction with our unaudited interim condensed consolidated financial statements and the Management’s Discussion and Analysis for the second quarter ended June 30, 2020 which are accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Aurinia will host a conference call and webcast to discuss the second quarter ended June 30, 2020 financial results today, Tuesday, August 11, 2020 at 4:30 p.m. ET. The webcast can be accessed on the investor section of the Aurinia website at www.auriniapharma.com. To participate in the teleconference please dial +1-877-407-9170 (Toll-free U.S. & Canada).

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (CNI) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. Voclosporin may result in a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (versus cyclosporine A), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable patent extension laws in other countries with anticipated pediatric extension. Further, a U.S. patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and AURORA trials into the product label.

On August 11, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, reported the grant of a new patent (number 10,736,940) entitled "Combined Preparations for the Treatment of Cancer" by the United States Patent Office (Press release, Immutep, AUG 11, 2020, View Source [SID1234563477]).

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This United States patent follows the grant of the corresponding European, Australian and Japanese patents (announced 23 May 2019, 21 June 2019 and 7 May 2020, respectively) and protects Immutep’s intellectual property relating to combined therapeutic preparations comprising its lead active immunotherapy candidate eftilagimod alpha ("efti" or "IMP321") and a chemotherapy agent. The chemotherapy agent is either a platinum-based anti-neoplastic agent, such as oxaliplatin or carboplatin, or a topoisomerase I inhibitor, such as topotecan.

This new patent highlights the ongoing and important steps being taken by the Company to protect its lead product candidate in a range of novel and highly relevant combination formats, in both chemo-immunotherapy and other immunotherapy settings.

The patent expiry date is 25 January 2035 (including 37 days of patent term adjustment).

On August 11, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported its financial results for the first half-year of 2020 (Press release, Evotec, AUG 11, 2020, View Source;announcements/press-releases/p/evotec-se-reports-first-half-year-2020-results-and-corporate-updates-5965 [SID1234563470]).

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OVERALL POSITIVE FINANCIAL PERFORMANCE REFLECTING GROWTH ACROSS ALL BUSINESS LINES
Significant Group revenue growth of 12% to € 231.0 m (H1 2019: € 207.1 m)
Revenue growth in both business segments: EVT Execute revenues up 16% to € 228.2 m (H1 2019: € 196.8 m); EVT Innovate revenues up 8% to € 44.6 m (H1 2019: € 41.2 m)
Adjusted Group EBITDA amounting to € 47.3 m (H1 2019: € 58.2 m)
Increased investments in unpartnered R&D of € 21.6 m (H1 2019: € 18.7 m)
Robust liquidity positon of € 275.7 m (31 December 2019: € 320 m)
No material impact by COVID-19 pandemic on overall financial and strategic development so far; slight delays in conclusion of contracts and milestone achievements

CONVINCING OPERATIONAL PROGRESS
Multiple new and extended drug discovery and development agreements
New 5-year contract with the US Environmental Protection Agency
Just – Evotec Biologics strengthens its position: contract with U.S. Department of Defense to develop and manufacture monoclonal antibodies for treatment and/or prevention of COVID-19 (after period-end)
Construction of first J.POD biologics manufacturing facility in Seattle, WA, USA progressing well
Evotec partner Zogenix received marketing approval from FDA for FINTEPLA; Evotec as supporting long-term partner will supply commercial API (Active Pharmaceutical Ingredients)
Continued progress in co-owned pipeline, despite certain COVID-19 related delays
New QRbeta initiative based on Evotec’s iPSC-based beta cell replacement therapy regained from Sanofi
New BRIDGE ("Autobahn Labs") and equity participations as well as successful follow-on financings

INCREASING EXPANSION OF INFRASTRUCTURE IN MULTIMODALITY
Establishment of new site Evotec GT in Austria, dedicated to gene therapy-based projects; multi-year gene therapy research alliance between Evotec GT and Takeda
Further expansion of Evotec’s multimodality platform into Antisense Therapy through cooperation with Secarna Pharmaceuticals

CORPORATE
Virtual Annual General Meeting 2020 approved all proposed agenda items
Election of new Supervisory Board Member Mr Kasim Kutay
Acquisition of "Biopark By Sanofi SAS" in Toulouse making Evotec the full owner of the Toulouse site; rebranding of the site into "Campus Curie Toulouse" (after period-end)

GUIDANCE FOR FULL-YEAR 2020 CONFIRMED WITH REGARD TO REVENUES AND ADJUSTED EBITDA, HIGHER INVESTMENTS IN R&D PLANNED
Unchanged business outlook in terms of revenue and adjusted EBITDA, taking into account currently visible COVID-19 effects
Group Revenues from contracts with customers expected to range from € 440 – 480 m (2019: € 446.4 m)
Adjusted Group EBITDA expected to be in the range of € 100 – 120 m (2019: € 123.1 m)
Due to promising investments in EVT Innovate, increase of guidance for "unpartnered R&D" to approx. € 45 m (before approx. € 40 m)

STRONG FINANCIAL POSITION
In the first six months of 2020 Evotec continued on its growth path: Group revenues from contracts with customers increased by 12% to € 231.0 m (H1 2019: € 207.1 m) due to a positive performance across all business lines, for the first time added revenues from Just – Evotec Biologics (€ 16.3 m) and despite the anticipated loss of payments of Sanofi for the Toulouse site (€ 7.5 m) from April 2020. Also, favourable exchange rate effects had a positive impact of € 2.4 m.

Thereof, base revenues accounted for € 223.2 m, an increase of 19% over the same period of the previous year (H1 2019: € 188.0 m), while revenues from upfront, milestone and licence payments decreased to € 7.8 m (H1 2019: € 19.1 m).

Due to the significant lower upfront, milestone and license payments as well as the anticipated expiring payments from Sanofi for the Toulouse site from April 2020 onwards, gross margin decreased to 23.0% (H1 2019: 30.8%).

In the first half-year of 2020, Evotec continued to strongly invest into its unpartnered R&D. Thus, the expenses for unpartnered R&D increased to € 21.6 m (H1 2019: € 18.7 m), mainly due to intensified research investments into oncology and platforms such as PanOmics and cell therapy. The lower partnered R&D expenses of € 8.2 m (H1 2019: € 10.6 m) were primarily related to the infectious disease portfolio. Whereas costs of the partnership with Sanofi in this area are predominantly reported as R&D expenses the full reimbursement by Sanofi is recognised under other operating income. Total R&D expenses of € 29.8 m nearly remained stable compared to 2019 (H1 2019: € 29.3 m).

The Group’s selling, general and administrative ("SG&A") expenses for the first half-year of 2020 increased by 22% to € 36.5 m (H1 2019: € 29.9 m), which mainly resulted from the overall staff increase and the related costs as well as from transaction and integration cost from equity engagements, the consolidation of Just – Evotec Biologics and the founding of Evotec GT.

Other operating result in the first six months of 2020 amounted to € 32.2 m (H1 2019: € 31.3 m) and was mainly influenced by R&D tax credits as well as recharges of Sanofi for ID Lyon. Due to a change in the tax regulations in Italian legislation, total R&D tax credits grew less as expected compared to prior period.

The operating income decreased to € 18.9 m (H1 2019: € 24.0 m), mainly due to the significantly lower upfront, milestone and licence revenues. Most of the half-year milestones are expected to be only slightly delayed, but not lost.

The lower upfront, milestone and licence revenues also affected the adjusted Group EBITDA which decreased by 19% to € 47.3 m (H1 2019: € 58.2 m). Favourable exchange rate developments had a positive impact of approx. € 1.7 m on the adjusted Group EBITDA.

The net result in the first half-year of 2020 amounted to € 7.3 m (H1 2019: € 10.7 m).

Evotec’s liquidity position in the first six months of 2020 continued to remain robust amounting to € 275.7 m (31 December 2019: € 320.0 m). The cash-outflow resulted mainly from the high investments in capex and equity investments.

CONVINCING OPERATIONAL PERFORMANCE IN BOTH BUSINESS SEGMENTS
In the first half of 2020, the EVT Execute segment continued its strong progress of the previous quarters.

Evotec signed multiple new drug discovery and development agreements, e.g. with Boston Pharmaceuticals and Ildong, as well as multiple undisclosed partners and extended or expanded existing long-term agreements (e.g. with Amgen, Takeda). Evotec’s wholly-owned US subsidiary Cyprotex was again selected by the US Environmental Protection Agency (EPA) as its preferred service partner for the next five years. The contract is worth up to $ 13 m.

Evotec’s fully-owned subsidiary Just – Evotec Biologics had a successful start with the J.POD construction, progressing well, and its first J.POD collaboration with MSD for the development of innovative technologies for the production of biologics of the highest quality. Further multiple new agreements were concluded (e.g. with ABL, Ology). After period-end, Just – Evotec Biologics entered into a partnership with the U.S. Department of Defense to develop and manufacture monoclonal antibodies (mAbs) for treatment and/or prevention of COVID-19. The contract with the DOD values up to $ 18.2 m.

Also, the Evotec Development Business showed very good performance and started strategic initiatives in the first half-year 2020, despite the extraordinary difficult circumstances especially at the Evotec site in Verona. In June 2020, Evotec’s long-term partner Zogenix received its marketing approval from FDA for the company’s drug FINTEPLA for Dravet & LGS syndromes, securing 7-year orphan drug exclusivity for commercial exploitation in the US. Evotec will continue to be the commercial manufacturing partner of Zogenix.

In its second segment, EVT Innovate, Evotec was also very successful within the first half-year 2020.

Evotec expanded its leading position in iPSC (Induced pluripotent stem cells). After having regained the global development and commercialisation rights of the iPSC-based diabetes cell therapy programme from Sanofi, Evotec intends to move this programme forward within its QRbeta initiative. Multiple other unpartnered iPSC based initiatives showed very good progress in the first half-year 2020 (e.g. Retinal Diseases).

Evotec’s long-term partner, Bayer AG, continues to advance its P2X3 antagonist BAY1817080, an asset originating from Evotec. The Phase IIa-PoC study had a positive outcome in patients with refractory chronic cough. Preparations for a Phase-IIb study in patients with refractory chronic cough are ongoing, as are preparations for further studies in additional indications.

Together with Samsara, Biocapital and KCK Evotec initiated "Autobahn Labs", a novel virtual early stage drug discovery incubator (BRIDGE) to design and execute an accelerated path to deliver transformational new therapies. Autobahn Labs already entered into a first-of-a-kind strategic collaboration with UCLA Technology Development Group to identify and advance the most promising areas of research.

Over the first half of 2020, Evotec continued to expand its strategy of generating upside through equity investments, e.g. in leon-nanodrugs, QUANTRO Therapeutics and Exscientia. Other equity participations were made as follow-on investments (e.g. Carrick) or small seed commitments (e.g. Cajal Neuroscience).

IMPORTANT STRATEGIC BUSINESS EXPANSION INTO NEW MODALITIES AND MARKETS
A very important step towards Evotec’s long-term vision of becoming a fully modality-agnostic drug discovery and development partnership company was the establishment of the new site Evotec GT in Austria, dedicated to research and development of gene therapy-based projects. In April, Evotec GT signed a long-term research alliance with Takeda covering selected Takeda gene therapy projects for core therapeutic areas like oncology, rare diseases, neuroscience and gastroenterology.

In June 2020, Evotec signed a strategic partnership with Secarna Pharmaceuticals in the field of Antisense Therapy and already initiated a first project with the aim to establish a pipeline of co-owned antisense oligonucleotide therapies.

Already in the first quarter of 2020, Evotec entered into the field of formulation nanotechnology by signing a strategic partnership with the Munich-based company leon-nanodrugs.

CORPORATE
Evotec’s shareholders at the virtual Annual General Meeting 2020 approved all proposals the Company’s Management put to vote with the required majority. The shareholders elected a new Supervisory Board member: Mr Kasim Kutay, CEO of Novo Holdings A/S, succeeds Dr Michael Shalmi, who resigned from the Board.

In May, Kara Carter, Executive Vice President Infectious Disease of Evotec, was appointed as President of the International Society of the Antiviral Research (ISAR).

Shortly after period-end, on 01 July 2020 Evotec acquired the "Biopark By Sanofi SAS" in Toulouse including all land and buildings of the Sanofi site. The acquisition will allow Evotec to significantly expand its existing capacities at its Toulouse site and to secure further, long-term growth of its Toulouse-based operations. The site will be rebranded into "Campus Curie Toulouse".

 

FINANCIAL GUIDANCE 2020
At present, the management of Evotec confirms the financial guidance published in the 2019 Annual Report on 26 March 2020 and confirmed in the Q1 Quarterly Statement on 14 May 2020 with regard to revenues and adjusted EBITDA.

Due to additional very promising investments in innovative technology platforms and development candidates in EVT Innovate, Evotec plans to invest even more in research and development. For this reason, the forecast for "unpartnered R&D" has been raised from previously approx. € 40 m to now approx. € 45 m.

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. Furthermore, the Management Board will present an outlook for the fiscal year 2020. The conference call will be held in English.

Conference call details

Date: Wednesday, 12 August 2020

Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page shortly before the event.

A replay of the conference call will be available for seven days after the conference and can be accessed in Europe by dialling +49 69 20 17 44 222 (Germany) or +44 20 3364 5150 (UK) and in the USA by dialling +1 844 307 9362. The access code is 315597273#. The on-demand version of the webcast will be available on our website: View Source

On August 11, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported that CEO, John M. Climaco, will be issuing a shareholder webinar on August 13th, 2020 at 4:30pm ET to discuss business developments and the progress of the Company’s lead candidate Berubicin, novel DNA-binding agent WP1244 and development agreement with WPD Pharmaceuticals for WP1122 (Press release, CNS Pharmaceuticals, AUG 11, 2020, View Source [SID1234563463]).

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Details of the webinar are below:

Date:

August 13th, 2020

Time:

4:30-5:00pm ET

Link:

View Source