On August 20, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that a license agreement has been reached with Biotheus Inc. ("Biotheus"), a privately held Chinese company based in Zhuhai, Guangdong, China (Press release, Alligator Bioscience, AUG 20, 2019, View Source [SID1234538879]). Under the license agreement, Alligator has granted Biotheus rights in Greater China (including Republic of China, Hongkong, Taiwan and Macau) to an antibody from ALLIGATOR-GOLD for the creation of up to three bispecific molecules. The license agreement includes an option for expanding the license to covering global rights.

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The license agreement includes an upfront of USD 1 million where Alligator receives USD 0.5 million upon signing and USD 0.5 million after 6 months of scientific-technical evaluation. Under the agreement Alligator is eligible to receive upfront, milestones and option fees of up to a total of approximately USD 142 million. This sum includes upfront and development milestones amounting to a total of approx. USD 52 million, global option fees up to a total of USD 90 million, plus royalties on future sales and share of sub-license revenue.

"This agreement is a great recognition of our antibody library and our proven expertise in generating high affinity antibodies against TNFR family members, and this collaboration with an up and coming Chinese biotech firm like Biotheus gives us an entrance to the fast advancing life science market in China", said Per Norlén, CEO Alligator Bioscience.

The Tumor Necrosis Factor Receptor super family (TNFR-SF) is a family of related receptors, sharing sequence homology. Several Alligator pipeline programs interact with members of the TNFR super family.

For further information, please contact:
Cecilia Hofvander, Director IR & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact persons set out above, at 4:35 p.m. CEST on August 20, 2019.

On August 20, 2019 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported that an abstract on the company’s CS1001-201 trial has been submitted to the upcoming 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, CStone Pharmaceauticals, AUG 20, 2019, View Source [SID1234538864]). This will mark the first release of CS1001-201 clinical study data since the trial began.

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CS1001 is an investigational anti-PD-L1 monoclonal antibody developed by CStone. CS1001 is currently being evaluated in multiple clinical trials in China, including one multi-arm Phase I study, two registrational Phase II studies, and three Phase III clinical studies. Based on previously released data, CS1001 has shown good overall safety and tolerability, and demonstrated promising clinical utility for combination therapy in various tumor types.

The CS1001-201 trial reported in the abstract is a single-arm, multi-center Phase II clinical study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of CS1001 monotherapy in relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (rr-ENKTL). The primary endpoint of the study is objective response rate (ORR).

ENKTL is a subtype of mature T-cell and NK-cell lymphoma. With its particular geographic predilection, the incidence rate of ENKTL is significantly higher in Asia than it is in Europe or North America. There are around 5,300 new ENKTL cases in China each year, which accounts for approximately 6% of all lymphoma incidences in the country. Approximately 50% of those ENKTL cases progress to rr-ENKTL. ENKTL is an aggressive malignancy with a dismal prognosis. Currently, there is no standard treatment for ENKTL patients in whom the L-asparaginase-based combination therapy has not been effective. CS1001-201 is the first clinical trial investigating an anti-PD-L1 antibody in rr-ENKTL patients, and durable anti-tumor activity has already been observed in the trial.

The abstract submitted to the 2019 ASH (Free ASH Whitepaper) Annual Meeting, if accepted, will highlight the safety and efficacy data from the CS1001-201 Phase II study in rr-ENKTL patients, and it will be the first report of the CS1001-201 trial and the fourth data update on CS1001 at a major scientific conference in 2019, following the ASCO (Free ASCO Whitepaper) Annual Meeting, the ESMO (Free ESMO Whitepaper) Annual Congress, and the CSCO Annual Meeting.

About CS1001

CS1001 is an investigational anti-PD-L1 monoclonal antibody being developed by CStone. Authorized by the U.S.-based Ligand Corporation, CS1001 was generated by the OMT transgenic animal platform, which can produce fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can potentially reduce the risk of immunogenicity and toxicities in patients, a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China and has demonstrated promising anti-tumor activity and tolerability.

CS1001 is currently being evaluated in multiple clinical trials including a bridging phase I trial in the USA, a multi-arm phase Ib dose-expansion study, two pivotal Phase II studies and three Phase III studies in China in various cancer types.

On August 20, 2019 Delcath Systems, Inc. ("Delcath," the "Company", "we", "our" or "us" (OTCQB: DCTH) reported that it has closed on its previously announced private placement with gross proceeds of $9.5 million at a combined price of $1,000 per Unit (Press release, Delcath Systems, AUG 20, 2019, View Source [SID1234538880]). Each Unit consists of one preferred share initially convertible into 16,667 shares of common stock at an initial conversion price of $0.06 per share and a common stock purchase warrant. Each whole warrant entitles the holder to purchase one share of common stock at an initial exercise price of $0.06 for a period of five years from the date of the Company’s anticipated reverse stock split. The Company has now raised a total of $29.5 million since July 2019.

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The offering is being led by fundamental healthcare investors, including Rosalind Advisors and Altium Capital.

Commenting on the announcement, Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath stated, "With this transaction completed, we have a cash runway beyond top line data, a clean capitalization table and the foundation for a possible path to NASDAQ listing. Looking forward, we are positioned for success through multiple value inflection points including full enrollment, top line data and NDA filing – targeted for Q4 2019, 1H 2020 and Q4 2020, respectively, in our registration trial for the treatment of metastatic Ocular Melanoma (mOM). mOM is a devastating disease of high unmet-need for which there is no approved standard-of-care in the United States and for which the Company has orphan drug designation."

Dr. Simpson added, "the management team has laid the foundation for a leading interventional oncology platform company and now has the resources, capital structure and operational resources to move forward its long-term priorities and growth plans, to maximize shareholder value."

The recapitalization enables Delcath to pursue its business plan to:

Develop therapies for cancers of the liver with high unmet medical need and no established standards of care, addressing a multi-billion-dollar opportunity in the United States and Europe;

Expand development of our platform to other indications, chemotherapies and organs; and;

Support our commercial partner medac in Europe (where CHEMOSTAT is approved) to maximize the opportunities set out in our December 2018 commercialization agreement.

The company recently announced the addition of John R. Sylvester to its Board of Directors. Mr. Sylvester is currently Chief Commercial Officer at BTG PLC, an international specialist healthcare company that develops and commercializes products targeting critical care, cancer and other disorders. The quality of BTG’s interventional medicine business played an integral part in its sale to Boston Scientific for $4.2 billion. The Company intends to leverage John’s expertise and experience in the commercialization of new medical technologies as Delcath prepares to enter US and ex-US markets.

Dr. Simpson concluded by stating, "I would like to thank the investors who took the time to assess this incredible opportunity and as a result have recognized the substantial value of Delcath’s assets, technology and clinical programs. Management and the Board are excited to work with our team of clinicians and key opinion leaders to make Melphalan/HDS available as a treatment option to improve patients’ lives and outcomes."

Roth Capital Partners acted as the sole placement agent for the offering. After the placement agent fees and estimated offering expenses payable by the Company, the Company has received net proceeds of approximately $8.6 million. The offering closed on Aug 19, 2019.

The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-1 with the Securities and Exchange Commission by August 21, 2019 for purposes of registering the resale of the shares of common stock issuable upon conversion of the preferred shares and upon exercise of the warrants issued in the private placement.

This notice does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On August 20, 2019 Araris Biotech AG reported the closing of an oversubscribed seed financing round of CHF 2.5 million with participation of Swiss investors Redalpine, Schroder Adveq and VI Partners (Press release, Araris Biotech, AUG 20, 2019, View Source [SID1234651277]). The proceeds will be used to develop a pipeline of proprietary antibody-drug conjugates (ADCs).

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Araris’ co-founder and Chief Executive Officer, Dr. Philipp Spycher, commented: "We are very pleased to announce that three renowned Swiss investors with a very strong track record have invested in Araris." Dr. Dragan Grabulovski, co-founder and chairman of the board, added: "Obtaining a seed financing from VCs just six months after incorporation of Araris validates the strong interest in our novel linker ADC technology. The funding will allow Araris to progress quickly towards generating key proof of principle data."

On August 20, 2019 Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ: EVTC) reported results and corporate updates for the second quarter 2009 (Press release, Evotec, AUG 20, 2019, View Source;announcements/press-releases/p/evotec-announces-strong-second-quarter-financial-results-4440 [SID1234538881]).

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Recent Highlights:
Strong quarterly performance leads to 46% revenue growth and 29% improvement of operating result
Further milestone payment received in drug discovery collaboration with Boehringer Ingelheim (after period-end)
Royalty income earned from DeveloGen
Several new discovery contracts signed
Failure of EVT 302 in smoking cessation; positive Phase I results with EVT 401; alliance with Roche on EVT 100 compound family
Execution of restructuring program "Evotec 2012 – Action Plan to Focus and Grow" yields" first results
Acquisition of Indian RSIPL to strategically leverage Discovery Alliance Business and create a global leader in drug discovery and development services (after period-end)
Revenue guidance increased; all other financial projections confirmed despite the acquisition of RSIPL

1. Operational performance

Strong quarterly performance leads to 46% revenue growth and 29% improvement of operating result
Evotec’s revenues for the second quarter 2009 grew strongly by 46% to EUR 10.5 million (Q2 2008: EUR 7.2 million). This is mainly the result of strong underlying revenues from Evotec’s Discovery Alliances Business, of a portion of the upfront payment for the EVT 100 compound family from Roche (EUR 0.9 million) as well as of license and royalty income totaling EUR 1.8 million from Roche and DeveloGen. Gross margin improved strongly to 38.8% (Q2 2008: 20.8%)
Evotec’s operating loss for the second quarter 2009 improved by 29% to EUR 8.9 million (Q2 2008: EUR 12.5 million) despite restructuring expenses in the amount of EUR 2.7 million. This improvement is a result of the Company’s strong top-line performance and its cost reductions in SG&A and R&D following the implementation of "Evotec 2012 – Action Plan to Focus and Grow".
Net loss for the second quarter 2009 amounted to EUR 8.6 million (Q2 2008: EUR 12.0 million).
Liquidity, which includes cash and cash equivalents (EUR 38.4 million), short-term investments (EUR 25.2 million) and auction rate securities (EUR 9.1 million), at the end of June 2009 amounted to EUR 72.7 million (December 31, 2008: EUR 92.4 million).

Royalty income earned from DeveloGen
The royalty income from DeveloGen was a result of the upfront payment DeveloGen received in its collaboration with Boehringer Ingelheim (published on May 13, 2009) on a target addressing insulin resistance. The target formed part of the Joint Venture between Evotec and DeveloGen which ended in 2005. As part of the agreement, DeveloGen maintained certain IP rights including those for the insulin target, and Evotec retained participation right on all future income DeveloGen might generate from the target. Under the terms of the agreement with Boehringer Ingelheim, DeveloGen received an upfront payment of EUR 7 million, and has the opportunity to earn potential additional milestone payments as well as tiered sales performance payments.

Further milestone payment received in drug discovery collaboration with Boehringer Ingelheim
On July 29, 2009, Evotec announced that a further research milestone, leading to payments to Evotec, has been successfully achieved in its drug discovery collaboration with Boehringer Ingelheim. The milestone was achieved for the identification and selection of a second compound to be advanced into preclinical development within an existing program. This represents the sixth milestone achieved in this multi-year, multi-target collaboration and is the second compound selected for pre-development in the last twelve months.

Several new discovery contracts signed
In July 2009, Evotec announced a significant research collaboration with Cubist Pharmaceuticals utilizing Evotec’s world-leading fragment-based drug discovery platform and a high-throughput screening collaboration with Alios Biopharma. In addition, Evotec-RSIL extended its library synthesis collaboration with Ferrer Grupo.

2. Status of clinical programs and partnering of assets

Failure of EVT 302 in smoking cessation; positive Phase I results with EVT 401; alliance with Roche on EVT 100 compound family
In April 2009, Evotec reported that the Phase II smoking cessation study of its MAO-B inhibitor EVT 302 failed to meet its clinical endpoints and Evotec subsequently stopped the development of the compound in this indication. All other clinical pipeline projects developed on track during the second quarter. On June 29, 2009, Evotec announced the successful completion of the first Phase I study with EVT 401, a potential novel oral treatment for inflammatory conditions such as Rheumatoid Arthritis. The compound was safe and well tolerated and demonstrated the desired pharmacodynamic activity in healthy volunteers. Evotec is now focusing its efforts on optimizing the oral dose formulation, completing the Phase I studies, and preparing for Phase II studies in Rheumatoid Arthritis.
Preparations of the Phase II clinical study for EVT 101 in treatment-resistant depression and a Phase I program for EVT 103 are on track to start in the second half of 2009. In March 2009, Evotec signed a partnership with Roche for the development of the EVT 100 compound family with total potential payments exceeding $300 million.

3. Update on Evotec 2012 Action Plan and cost reductions

Execution of restructuring program "Evotec 2012 – Action Plan to Focus and Grow" yields first results
Based on the "Evotec 2012 – Action Plan to Focus and Grow" Evotec implemented strict restructuring measures during the course of the second quarter. Evotec initiated headcount reductions in administrative functions by 20% and, following the setback in the progress of Evotec’s clinical pipeline, headcount reductions in the clinical development group by approximately 50%. In addition, the Company re-engineered its drug discovery and development operations to more efficiently leverage its research and development infrastructure. All proprietary programs are now managed through Evotec’s European operations and the Company is on course to finally close its US operations in South San Francisco, California, by the end of the third quarter.
As a consequence of these measures, as compared to the prior year, Evotec’s headcount as of June 30, 2009 decreased by 60 people to 370; R&D expenses were down 35% and SG&A expenses were down 11% in the second quarter, despite the fact that in the same quarter last year, the US research and developments programs were consolidated into European operations only after May 2. Expenses are expected to further decline and the full impact of Evotec’s restructuring will be reflected in the financial results for the second half of 2009.

4. Acquisitions

Acquisition of Indian RSIPL to strategically leverage DAB and create a global leader in drug discovery and development services
On August 6, 2009, Evotec announced the acquisition of a controlling majority shareholding of the Indian organization Research Support International Private Limited (RSIPL) for approximately EUR 2.8 million in cash, a portion of which includes a potential earn-out. With this acquisition Evotec expands its chemistry capacity by approximately 160 scientists and delivers on its strategy as described in the "Evotec 2012 – Action Plan to Focus and Grow" to create the global partner of choice for the pharmaceutical and biotechnology industries in discovery and early development services. This transaction adds a complementary drug discovery operation and capability in a cost-effective location to Evotec’s already world-leading discovery platform and efficiently increases its ability to deliver high quality drug discovery and development services to its partners.
On May 7, 2009, Evotec also acquired the zebrafish screening operations of Summit Corporation plc to further strengthen its state-of-the-art technology platform. These strategic technology and capacity additions further validate Evotec’s goal to become the number one global provider of discovery and development services.

5. Guidance

Revenue guidance increased; all other financial targets confirmed despite the acquisition of RSIPL
The Company increases its 2009 revenue guidance to above EUR 40 million (previously above EUR 35 million) and confirms all other financial targets for the fiscal year 2009 published in March despite the acquisition of RSIPL. Liquidity at the end of June 2009 is at EUR 72.7 million. With the contribution of milestone receipts from research collaborations and the full impact of Evotec’s restructuring measures, cash consumption is expected to be reduced considerably in the second half of the year. On this basis, Evotec remains confident to deliver on its liquidity guidance of above EUR 65 million by the end of 2009.

Conference Call
The Company is going to hold a conference call to discuss the results:

Conference call details
Date: Friday, August 7, 2009
Time: 09.30 a.m. CEST
08.30 a.m. BST
03.30 a.m. US time (East Coast)

From Europe: +49.(0)69.5007 1308 (Germany)
+44.(0)20.7806 1956 (UK)
From the US: +1.718.354 1388
Access Code: 8676443

A simultaneous slide presentation for participants dialing in via phone is available at www.equitystory.com, password: evotec0809.

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 24 hours and can be accessed in Europe by dialing +49.(0)69.22222 0418 (Germany) or +44.(0)20.7806 1970 (UK) and in the US by +1.718.354 1112. The access code is 8676443#. The on-demand version of the webcast will be available on our website: www.evotec.com – Investors – Financial Reports.