On August 5, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first half-year of 2020 on Wednesday, 12 August 2020 (Press release, Evotec, AUG 5, 2020, View Source;announcements/press-releases/p/evotec-se-to-report-first-half-year-2020-results-on-12-august-2020-5961 [SID1234562862]).

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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)

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com 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 4, 2020 T-Cure Bioscience, Inc., a privately held company focused on developing autologous T cell receptor (TCR) therapy products for the treatment of solid tumors, reported that the Company has extended its ongoing research collaboration with the National Heart Lung and Blood Institute (NHLBI), through a formal Collaborative Research and Development Agreement (CRADA) to advance the Company’s HERV-E targeting TCR therapy for renal cell cancer (Press release, T-Cure Bioscience, AUG 4, 2020, View Source [SID1234572979]). Additionally, T-Cure has amended an existing license to expand to worldwide rights for the intellectual property it licensed from NHBI related to the anti-HERV-E TCR product. This TCR therapy is currently in a Phase 1 trial at NHLBI for the treatment of metastatic clear cell Renal Cell Carcinoma (ccRCC) that failed an angiogenic inhibitor and a checkpoint inhibitor. T-Cure has been actively collaborating for the past 18 months with NHLBI on the research and development of the HERV-E-specific TCR.

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Under the CRADA, T-Cure and NHLBI will collaborate to develop a companion test to identify HERV-E transcripts in patients’ tumors as well as to identify additional therapy candidates targeting HERV-E using the Company’s proprietary TCR discovery platform, iSORTTM. Additionally, NHLBI and T-Cure plan to conduct preclinical experiments characterizing novel TCR and will evaluate various drug and TCR combination anti-tumor therapeutic strategies.

"We are extremely excited to work with the NIH to advance this novel HERV-E TCR therapy candidate through preclinical and clinical development," stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "Of note, the TCR was isolated from a dominant killer T cell clone of a late stage metastatic ccRCC patient who responded to an immunotherapy and survived 4 years. The HERV-E-specific TCR represents a rare opportunity for us to specifically target ccRCC, a potential T cell responsive solid tumor."

The HERV-E target is one of the quiescent Human Endogenous Retrovirus (HERV) sequences that are activated during tumor development. A growing number of HERV genes and proteins are expressed in different cancers raising the possibility that HERV derived antigens might represent excellent targets for tumor immunotherapy. Its expression in renal cell carcinoma (RCC) is highly selective, with no transcripts detected in any normal tissues. In contrast to well-studied antigens such as NY-ESO-1 and MAGE, HERV-E represents a new frontier of TCR targets with significant clinical potential for immunotherapy.

On August 4, 2020 Astellas reported that Financial Results for 1Q/FY2020 (Press release, Astellas, AUG 4, 2020, View Source [SID1234564041])

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FY2020
Business Results for 1Q (August 4, 2020)
Financial Results (Q1/FY2020) （795KB）
Supplementary Documents (Q1/FY2020) （770KB）
Presentation Material for Information Meeting (Q1/FY2020) （759KB）
On-demand Replay of Information Meeting

FY2019
Business Results (May 14, 2020)
Financial Results (FY2019) （1,291KB）
Supplementary Documents (FY2019) （1,156KB）
Presentation Material for Information Meeting (FY2019) （756KB）
On-demand Replay of Information Meeting
Business Results for 3Q (January 31, 2020)
Financial Results (Q3/FY2019) （334KB）
Supplementary Documents (Q3/FY2019) （791KB）
Presentation Material for Information Meeting (Q3/FY2019) （941KB）
On-demand Replay of Information Meeting
Business Results for 2Q (October 31, 2019)
Financial Results (Q2/FY2019) （328KB）
Supplementary Documents (Q2/FY2019) （423KB）
Presentation Material for Information Meeting (Q2/FY2019) （964KB）
On-demand Replay of Information Meeting
Business Results for 1Q (July 30, 2019)
Financial Results (Q1/FY2019) （253KB）
Supplementary Documents (Q1/FY2019) （1,292KB）
Presentation Material for Information Meeting (Q1/FY2019) （862KB）

FY2018
Business Results (April 25, 2019)
Financial Results (FY2018) （347KB）
Supplementary Documents (FY2018) （294KB）
Presentation Material for Information Meeting (FY2018) （1,492KB）
Business Results for 3Q (January 31, 2019)
Financial Results (Q3/FY2018) （347KB）
Supplementary Documents (Q3/FY2018) （508KB）
Presentation Material for Information Meeting (Q3/FY2018) （871KB）
Business Results for 2Q (October 31, 2018)
Financial Results （312KB）
Supplementary Documents （500KB）
Overview of R&D Pipeline （97KB）
Presentation Material for Information Meeting （634KB）
Business Results for 1Q (July 27, 2018)
Financial Results （305KB）
Supplementary Documents （326KB）
Overview of R&D Pipeline （95KB）
Presentation Material for Information Meeting （507KB）

FY2017
Business Results (April 26, 2018)
Financial Results （429KB）
Supplementary Documents （417KB）
Overview of R&D Pipeline （94KB）
Presentation Material for Information Meeting (April 26, 2018) （695KB）
Business Results for 3Q (January 31, 2018)
Financial Results （263KB）
Supplementary Documents （507KB）
Overview of R&D Pipeline （93KB）
Presentation Material for Information Meeting (January 31, 2018) （585KB）
Business Results for 2Q (October 31, 2017)
Financial Results （259KB）
Supplementary Documents （512KB）
Overview of R&D Pipeline （94KB）
Presentation Material for Information Meeting (October 31, 2017) （557KB）
Business Results for 1Q (July 28, 2017)
Financial Results （366KB）
Supplementary Documents （315KB）
Overview of R&D Pipeline （95KB）
Presentation Material for Information Meeting (July 28, 2017) （793KB）

On August 4, 2020 (the "Effective Date"), Generex Biotechnology Corporation (the "Company") and three (two of whom are affiliates) institutional accredited investors (each a "Buyer" and, collectively, the "Buyers") reported entered into a securities purchase agreement (the "Securities Purchase Agreement") pursuant to which the Company sold and issued to the Buyers an aggregate of 5,102,040 shares (the "Common Shares") of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at an aggregate price of $2,000,000 (the "Private Placement") (Filing, 8-K, Generex, AUG 4, 2020, View Source [SID1234563163]).

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Pursuant to the Securities Purchase Agreement, the Company issued to the Buyers (i) Series A Warrants to purchase 5,102,040 shares of Common Stock in the aggregate (the "Series A Warrants") with an initial exercise price equal to $0.392 per share (the "Series A/B Exercise Price"), (ii) Series B Warrants to purchase 15,306,122 shares of Common Stock in the aggregate (the "Series B Warrants") with an initial exercise price equal to the Series A/B Exercise Price; (iii) Series C Warrants to purchase the number of shares of Common Stock equal to Maximum Eligibility Number (as defined therein) (the "Series C Warrants") at an initial exercise price equal to $0.539 per share; and (iv) Series D Warrants to purchase the number of shares Common Stock equal to the Maximum Eligibility Number (as defined therein) (the "Series D Warrants" and together with the Series A Warrants, the Series B Warrants and the Series C Warrants, the "Warrants" and the Warrants together with the Common Shares and the shares of Common Stock underlying the Warrants, the "Securities") at an exercise price equal to $0.001 per share, in each case, subject to adjustment and beneficial ownership limitations set forth therein. Subject to the satisfaction or waiver of certain conditions set forth in the Series A Warrants, the Company may force the Buyers to exercise the Series A Warrants in full on the twenty second (22nd) trading day (the "Forced Exercise Date") after the effectiveness of the Company’s registration statement that registers all of the Common Shares and shares underlying the Warrants. The exercise price set forth in each of the Series A Warrants, the Series B Warrants and Series C Warrants is subject to adjustment on certain trigger dates as provided in each such Warrant. The holders of the Series A Warrants, Series B Warrants and Series C Warrants shall be allowed a cashless exercise if a registration statement registering the Securities is not effective within 180 days following the issuance of such Warrants. On certain trigger dates as set forth in the Series D Warrants, the Series D Warrants will become exercisable into a number of shares of Common Stock that would have been issued on the issuance date and upon exercise of the Series A Warrants and Series B Warrants had the purchase price per share and exercise price of the Series A Warrants and Series B Warrants been equal to the applicable reset price as set forth in the Series D Warrant.

The Company expects to receive gross proceeds from the Private Placement of $2.0 million initially, before deducting transaction costs, fees and expenses payable by the Company. The Company intends to use the net proceeds of the Private Placement to first pay certain accrued expenses and the remaining proceeds for working capital purposes and acquisitions.

As required by the Securities Purchase Agreement, each director and officer of the Company has previously entered into a lock-up agreement with the Company whereby each director and officer has agreed that during the period commencing from the date of such agreement until 90 days after the earliest to occur of (x) such time as all of the Securities may be sold without restriction or limitation pursuant to Rule 144 ("Rule 144") under the Securities Act of 1933, as amended (the "1933 Act") and without the requirement to be in compliance with Rule 144(c)(1), (y) the one (1) year anniversary of the Issuance of the Warrants, and (z) the date that the initial registration registering the Securities has been declared effective by the Securities and Exchange Commission (the "SEC"); provided, that, this clause (z) shall only apply if there are no limitations as to the number of Securities registrable pursuant to Rule 415 under the 1933 Act, such director or officer will not sell, hypothecate, pledge, grant any option to purchase, make any short sale or otherwise dispose of or agree to dispose of, directly or indirectly, any shares of Common Stock or Common Stock Equivalents, or establish or increase a put equivalent position or liquidate or decrease a call equivalent position with respect to any shares of Common Stock or Common Stock equivalents owned by such director or officer.

The foregoing descriptions of the Securities Purchase Agreement and the Warrants do not purport to be complete and are qualified in their entirety by reference to the complete text of the Securities Purchase Agreement and the forms of Warrants, which are attached hereto as Exhibits 10.1 and 4.1, 4.2, 4.3 and 4.4, respectively, to this Current Report on Form 8-K and are hereby incorporated by reference into this Item 1.01.

Registration Rights

In connection with the Private Placement, the Company and the investors entered into a Registration Rights Agreement dated August 4, 2020 (the "Registration Rights Agreement") providing for the registration for resale of the Securities (the "Registration Statement") to be filed with the SEC on or prior to twelve (12) business days after the Effective Date. The Company has agreed to use its commercially reasonable best efforts to cause the Registration Statement to be declared effective as soon as possible, but in no event later than the earlier of the (x) seventy fifth (75th) day after the Effective Date and (y) fifth (5th) business day after the Company is notified by the SEC that the Registration Statement will not be reviewed. The Company shall also be required to register Securities not covered by the Registration Statement in accordance with the provisions of the Registration Rights Agreement. If the Company does not meet its filing or effectiveness deadlines or does not maintain its listing on the OTC QB, then, the Company must pay a cash amount to the Buyers equal to two percent (2.0%) of the aggregate Purchase Price for each missed deadline or maintenance failure and then again on successive dates until such filing or effectiveness is achieved or such failure is cured. In the event these payments are not timely made interest at a rate of to 1.5% per month on late payments shall accrue until such amounts are paid.

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Registration Rights Agreement, which is attached hereto as Exhibit 4.5 to this Current Report on Form 8-K and is hereby incorporated by reference into this Item 1.01.

Item 3.02 Unregistered Sales of Equity Securities.

The information disclosed in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.02. The sale and issuance of the Common Stock and Warrants in the Private Placement have been determined to be exempt from registration under the 1933 Act in reliance on Section 4(a)(2) thereof and Rule 506 of Regulation D promulgated thereunder as a transaction by an issuer not involving a public offering, in which the investors are accredited and have acquired the securities for investment purposes only and not with a view to or for sale in connection with any distribution thereof. Such securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Item 3.03 Material Modification to Rights of Security Holders.

On August 4, 2020 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2020 (Press release, Cerus, AUG 4, 2020, View Source [SID1234562785]).

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Recent developments and highlights include:

Q2 2020 Total Revenue of $26.8 million – driven by robust year-over-year platelet kit sales growth in the U.S. and strong plasma and illuminator sales in our EMEA region. Total revenue comprised of (in millions, except %):

Reaffirming 2020 full year product revenue guidance range of $89 million to $93 million – an approximately 20% to 25% increase over 2019 reported product revenue.
Submitted a pre-market approval supplement (PMA-S) to the FDA for pathogen reduced cryoprecipitated fibrinogen complex with 5-day post-thaw storage.
Finalized INTERCEPT Red Cell CE Mark modular submission schedule, in agreement with our notified body, under new MDR submission pathway, providing clarity on the timing and pathway for red blood cells, the most frequently transfused blood component globally.
Reached agreement with FDA on chronic transfusion clinical data required for PMA submission and submitted clinical protocol amendment for the existing Phase 3 RedeS study to allow for enrollment of sickle cell and thalassemia patients.
Announced study results demonstrating that the INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components intended for transfusion.
Awarded a five-year tender by the Hong Kong Red Cross Blood Transfusion Services for INTERCEPT Blood System for platelets.
Cash, cash equivalents, and short-term investments of $136.5 million at June 30, 2020.
"The benefits of pathogen reduced blood products have never been so prominent as they are now during the COVID-19 pandemic. Our Q2 results reflect the highest quarterly product revenue we have recorded to date at $21.5 million. This pandemic has made clear to us not only the resilience of our business during this time, but also the essential role that pathogen inactivation plays in helping ensure the security and safety of the blood supply chain. It has also resulted in greater focus on strategic planning and pandemic preparedness by blood centers," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Demand for INTERCEPT platelet kits continued to be strong in the U.S. as blood centers and hospitals adopt pathogen reduction to be compliant with the FDA guidance document on platelet safety, which has a compliance deadline that is now less than 8 months away."

"Our development programs continued to make progress during the quarter. In May, we submitted our PMA-S for pathogen-reduced cryoprecipitated fibrinogen complex, which could result in potential FDA approval by the end of this year. In addition, meetings with the European and U.S. regulatory agencies in the quarter resulted in more expedited and clear pathways to potentially gain regulatory approvals of the INTERCEPT red blood cell system," continued Greenman.

Revenue

Product revenue during the second quarter of 2020 was $21.5 million, compared to $18.2 million during the same period in 2019. Revenue growth in the quarter benefited from robust year-over-year platelet kit sales in the U.S., in addition to strong plasma kit demand and an increase in illuminator sales in our EMEA region. Year-to-date product revenue totaled $40.1 million, an increase of 12% compared to the same period in 2019.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $5.3 million during the second quarter of 2020, compared to $4.3 million during the same period in 2019, as a result of increasing INTERCEPT red blood cell clinical and development activities. Year-to-date government contract revenue totaled $11.4 million, compared to $8.7 million in the first half of 2019. The total potential value of the current BARDA agreement is $214 million with $55 million recognized as revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded partially with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the second quarter of 2020 were 55% and consistent with the prior year period. Gross margins during the first half of 2020 were 55% compared to 54% reported in the first half of 2019.

Operating Expenses

Total operating expenses for the second quarter of 2020 were $31.7 million compared to $31.2 million for the same period the prior year. Year-to-date, operating expenses totaled $63.5 million compared to $60.8 million for the first half of 2019.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2020 totaled $16.1 million, compared to $16.7 million for the second quarter of 2019. The year-over-year decline was due to lower travel and marketing related expenses as a result of the COVID-19 pandemic. Year-to-date SG&A expenses totaled $32.0 million compared to $32.9 million for the first half of 2019.

Research and development (R&D) expenses for the second quarter of 2020 were $15.6 million, compared to $14.4 million for the second quarter of 2019. The increase in year-over-year R&D expenses was due to higher expenses associated with initiatives to expand platelet label claims and development of our INTERCEPT red blood cell system. Year-to-date R&D expenses totaled $31.4 million compared to $27.9 million for the first half of 2019.

Net Loss

Net loss for the second quarter of 2020 was $14.9 million, or $0.09 per diluted share, compared to a net loss of $17.6 million, or $0.13 per diluted share, for the second quarter of 2019. Year-to-date net loss was $31.3 million, or $0.19 per diluted share, compared to $36.4 million, or $0.26 per diluted share, in the first half of 2019.

Cash, Cash Equivalents and Investments

At June 30, 2020, the Company had cash, cash equivalents and short-term investments of $136.5 million, compared to $85.7 million at December 31, 2019.

At June 30, 2020, the Company had approximately $39.5 million in outstanding term loan debt, compared to $39.4 million in outstanding term loan debt at December 31, 2019.

2020 Product Revenue Guidance

The Company expects 2020 product revenue to be in the range of $89 million to $93 million, unchanged from the guidance originally provided on January 13, 2020. The guidance range represents approximately 20% to 25% growth compared to 2019 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 6681405. The replay will be available approximately three hours after the call through August 18, 2020.