On May 14, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the quarter ended March 31, 2019 and provided a corporate update (Press release, Gossamer Bio, MAY 14, 2019, View Source [SID1234536266]).

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"In the three months since our initial public offering, we have made significant further advancements in building an operationally efficient biotechnology company with a diversified portfolio of potential new therapies in multiple disease areas with high unmet need," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. "This is an exciting and productive time for Gossamer, and we look forward to numerous data readouts in 2020. Our team’s track record of success and our strong balance sheet positions us well to realize our goal of becoming an industry leader in immunology, inflammation and oncology."

Pipeline Updates

GB001: Oral DP2 Antagonist for Asthma and Allergic Disease

Enrollment in the Phase 2b LEDA study in moderate-to-severe eosinophilic asthma is on track, with results from an interim analysis expected in the first half of 2020.

Screening patients in the TITAN Phase 2 proof-of-concept study in chronic rhinosinusitis with and without nasal polyps is underway.

In February 2019, Gossamer presented results of a post-hoc analysis of a GB001 study at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2019 Annual Meeting. The analysis suggested that high baseline levels of Fractional exhaled Nitric Oxide (FeNO), a marker of airway inflammation, could potentially be used as a prognostic marker for GB001 response in the treatment of asthma, as marked reductions in FeNO levels as well as greater numeric improvements in lung function and asthma control were observed relative to placebo in patients with high baseline FeNO as compared to patients with low baseline FeNO. Gossamer plans to further assess the utility of FeNO as a prognostic marker in future studies.

Initiation of a Phase 2 proof-of-concept study in chronic spontaneous urticaria is planned for the second half of 2019

GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

Dosing of Phase 1 safety studies has been completed, and thus far the drug has been well tolerated with no serious adverse events observed to date.

Site initiation and patient screening for a Phase 1b study in patients with PAH is expected in the second quarter of 2019.

GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

A Phase 1 safety study in healthy volunteers was recently completed, in which the drug was generally well tolerated with no serious adverse events observed to date.

An Investigational New Drug Application (IND) for GB004 is now active, following a first quarter filing with the U.S. Food and Drug Administration (FDA).

Screening patients in a Phase 1b study in active mild-to-moderate ulcerative colitis is underway.

GB1275: Oral CD11b Modulator for Oncology Indications

An IND has been filed with the FDA and the initiation of a Phase 1/2 study in advanced solid tumor indications is planned for the second half of 2019, subject to the FDA 30-day review period.

Corporate Updates

Closed Initial Public Offering (IPO)

In February 2019, Gossamer closed its IPO, which generated over $291 million in net proceeds.

Secured debt facility for up to $150 million.

In May 2019, Gossamer entered into a five-year $150 million senior debt facility, with $30 million funded at closing, and access to the remaining $120 million subject to the achievement of certain clinical development milestones and other customary conditions.

Financial Results for Quarter Ended March 31, 2019

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2019, were $481.2 million. The Company expects current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the second half of 2021.

Research and Development (R&D) Expenses: For the quarter ended March 31, 2019, R&D expenses were $25.0 million, including $1.3 million of stock-based compensation, compared to R&D expenses of $2.6 million for the quarter ended March 31, 2018. The increase was primarily due to costs related to the research and development of GB001, GB002 and GB004.

In-Process Research and Development (IPR&D) Expenses: For the quarter ended March 31, 2019, IPR&D expenses were $1.0 million, compared to $20.9 million for the quarter ended March 31, 2018, which included $19.3 million associated with the issuance of stock in connection with the acquisition of GB001.

General and Administrative (G&A) Expenses: For the quarter ended March 31, 2019, G&A expenses were $8.0 million, which included $1.8 million of stock-based compensation.

This compared to G&A expenses of $2.6 million for the quarter ended March 31, 2018, which included $0.6 million of stock-based compensation. The increase was primarily attributable to personnel-related expenses, professional and legal fees, and stock-based compensation.

Net Loss: For the quarter ended March 31, 2019, net loss was $32.6 million, or a loss of $0.90 per share.

Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 8:30 a.m. ET today, Tuesday, May 14, 2019, to discuss its first quarter 2019 financial results and provide a corporate update.

The live audio webcast may be accessed through the Events/Presentations page in the Investors section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 7791474
Domestic Dial-in Number: (866) 221-1654
International Dial-in Number: (470) 495-9466
Live Webcast: View Source

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.

On May 14, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first quarter of 2019 (Press release, Evotec, MAY 14, 2019, View Source;announcements/press-releases/p/evotec-se-reports-first-quarter-2019-results-and-provides-corporate-update-5805 [SID1234536265]).

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STRONG FINANCIAL PERFORMANCE

Group revenues up 27% to € 103.8 m (Q1 2018: € 81.6 m)

Adjusted Group EBITDA up 114% to € 30.0 m (Q1 2018: € 14.0 m)

Unpartnered R&D expenses of € 8.1 m (Q1 2018: € 4.6 m)

Strong strategic liquidity position of € 141.6 m despite full repayment of bridge loan facility (total volume: € 140 m) drawn in August 2017 in context of Aptuit acquisition (last tranche after period-end)

EXCELLENT OPERATIONAL AND SCIENTIFIC PROGRESS

Multiple new and extended drug discovery and development agreements

Good progress with co-owned, clinical pipeline; multiple important milestone achievements

Consolidation of Basel activities into Toulouse site with transfer of projects to increase overall efficiency of high-throughput screening operations

New licence agreement with Galapagos in fibrosis

Anti-infective research alliances with Helmholtz (HZI) and GARDP

Agreement with The Mark Foundation in immuno-oncology based on Evotec’s discovery platform TargetAlloMod

Participation in further financing rounds of Eternygen and Exscientia

Strategic collaboration on precision medicine for colorectal cancer with Indivumed (after period-end)

CORPORATE

Conversion into European Company (SE) effective 29 March 2019

FINANCIAL GUIDANCE 2019 CONFIRMED

1. STRONG FINANCIAL PERFORMANCE

In Q1 2019, Evotec’s Group revenues increased by 27% to € 103.8 m (Q1 2018: € 81.6 m). This increase was driven primarily by the strong performance in the base business and milestone contributions. Revenues from milestones, upfronts and licences significantly increased to € 10.1 m in comparison to the previous year (Q1 2018: € 2.7 m) and included, amongst others, milestone payments from Bayer and Boehringer Ingelheim.

In Q1 2019, Evotec focused its unpartnered R&D expenses of € 8.1 m primarily on projects in the metabolic and oncology space as well as on its iPSC research. Its partnered R&D expenses of € 6.3 m on its infectious disease portfolio were fully reimbursed under other operating income by its partner Sanofi. This split into unpartnered and partnered R&D expenses had not been applied in Q1 2018, where total R&D expenses of € 4.6 m were recorded compared to € 14.4 m in the reporting quarter.

In Q1 2019, the Group’s selling, general and administrative ("SG&A") expenses increased as expected by 11% to € 14.8 m (Q1 2018: € 13.3 m). This increase resulted primarily from increased personnel expenses following the addition of Evotec ID (Lyon), consultancy fees, and from overall Company growth.

The significant step-up in the adjusted Group EBITDA for Q1 2019 to € 30.0 m (Q1 2018: € 14.0 m) resulted mainly from the strong performance in the base business, considerably higher milestone contributions, and effects from the first-time application of the new accounting standard IFRS 16, yielding an adjusted EBITDA margin of 28.9% (Q1 2018: 17.2%).

Evotec’s operating result amounted to € 19.1 m in Q1 2019 (Q1 2018: € 6.5 m) being positively impacted by higher R&D tax credits and reimbursed R&D expenses from Sanofi. The Company’s net result in Q1 2019 amounted to € 13.1 m (Q1 2018: € 3.5 m).

Evotec ended Q1 2019 with a strong liquidity of € 141.6 m (31 Dec 2018: € 149.4 m), which was composed of cash and cash equivalents (€ 111.6 m) and investments (€ 30.0 m). Shortly after period-end, Evotec completed the repayment of the € 140 m debt bridge facility within less than two years after it was drawn down in context of the acquisition of Aptuit in August 2017, mainly due to the strong cash inflow from Evotec’s operational activities and through refinancing at significantly more attractive conditions.

2. EXCELLENT OPERATIONAL AND SCIENTIFIC PROGRESS – EVT EXECUTE & EVT INNOVATE
The EVT Execute segment continued its strong progress of previous quarters also in Q1 2019. Evotec signed multiple new and extended drug discovery and development agreements in the first quarter of 2019. Multiple EVT Execute alliances recorded milestone achievements, such as the chronic cough alliance with Bayer and the pain alliance with Boehringer Ingelheim, contributing to the strong performance of this segment. The high-throughput ADME-tox testing business of Cyprotex continued its excellent performance.

EVT Innovate recorded the acceleration of first-in-class science across various ventures in Q1 2019. Existing pipeline projects continued to move forward. New agreements were signed in the first quarter of 2019, e.g. a new licence agreement with Galapagos in fibrosis, and two new partnerships in oncology with The Mark Foundation (immuno-oncology) and Indivumed (focus on precision medicine in colorectal cancer, after period-end). In addition, Evotec’s BRIDGE model is gaining even more momentum with further projects selected in its existing BRIDGE initiative LAB150. An ongoing clinical trial with Second Genome was put on hold (after period end).

Regarding its strong focus on infectious diseases, Evotec entered into new alliances with Helmholtz and GARDP (The Global Antibiotic Research and Development Partnership) to accelerate much-needed innovation in this field.

3. CORPORATE
CONVERSION INTO EUROPEAN COMPANY (SE) EFFECTIVE 29 MARCH 2019

Effective 29 March 2019, Evotec completed its conversion into a company under European law (Societas Europaea, "SE") with its registration in the commercial register. The new legal form has no impact on the Company’s day-to-day operations and reflects the continuing European and international focus of the whole Evotec Group, with major subsidiaries in France, Germany, Italy, UK and the USA.

4. FINANCIAL GUIDANCE 2019 CONFIRMED

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 fiscal year 2019. The conference call will be held in English.

Conference call details
Date: Tuesday, 14 May 2019

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

From Germany: +49 69 201 744 220

From France: +33 170 709 502

From Italy: +39 02 3600 6663

From the UK: +44 20 3009 2470

From the USA: +1 877 423 0830

Access Code: 35899832#

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 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 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 315534322#. The on-demand version of the webcast will be available on our website: View Source

On May 14, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that Steve Hoerter, President and Chief Executive Officer, will present at the UBS Global Healthcare Conference on Monday, May 20 at 9:00 AM ET at the Grand Hyatt New York (Press release, Deciphera Pharmaceuticals, MAY 14, 2019, View Source [SID1234536264]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On May 14, 2019 DCprime, the front-runner in the field of relapse vaccines, reported presentations of additional preclinical data sets for its lead program, DCP-001, at the 7th CCBIO Annual Symposium and the 2019 CIMT (Free CIMT Whitepaper) Annual Meeting (Press release, DCPrime, MAY 14, 2019, View Source [SID1234536263]). The data supports key product characteristics and sheds additional light on the mechanism-of-action of DCP-001, a whole cell-based vaccine derived from the company’s proprietary DCOne human leukemic cell line. DCP-001 is currently studied in an international Phase II trial in AML patients who are ineligible for hematopoietic stem cell transplantations.

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"While we are making constant progress evaluating DCP-001 in the clinic in AML and preparing additional trials in MDS and Multiple Myeloma, we continue to strengthen the body of preclinical data supporting this program," commented Dr Jeroen Rovers, CMO of DCprime. "The preclinical results and animal models we have generated in our collaboration with the University of Bergen provide further insights into the vaccine’s mechanism-of-action and confirm several key product characteristics relevant to our approach. Overall, these data strongly support the rationale of DCP-001 as a relapse vaccine providing immune control over residual disease in hematological malignancies."

DCOne cells endogenously express known and unknown tumor-associated antigens. In the DCP-001 manufacturing process, DCOne cells are differentiated and matured into cells with a mature dendritic cell phenotype, which is responsible for the strong immunogenic properties of the vaccine.

In its collaboration with the University of Bergen, Norway, DCprime has established a preclinical mouse model to study DCP-001 vaccinations in monotherapy and in combination therapy settings. The collaboration is supported by the Horizon 2020 EU grant AML-VACCiN. The data which were presented yesterday at the 7th CCBIO Annual Symposium showed that DCP-001 was able to suppress tumor growth in humanized immunocompetent mice. The results also demonstrated that the transformation of DCOne leukemic cells into DCP-001 leads to an immunogenic shift. Whereas the parental leukemic cells were poorly immunogenic, DCP-001 proved highly immunogenic, making it an attractive cancer vaccine candidate. Furthermore, DCP-001 induced the production of a broad range of pro-inflammatory cytokines in peripheral blood mononuclear cells (PBMCs) derived from healthy donors.

In preclinical studies, which will be presented at the upcoming 2019 CIMT (Free CIMT Whitepaper) Annual Meeting, DCprime was able to demonstrate that human antigen presenting cells (APCs) efficiently process DCP-001 through phagocytosis. These in vitro data suggest that in vivo, upon intradermal injection, DCP-001 will induce a strong inflammatory response, and is ingested by both resident and attracted host APCs, which subsequently prime tumor-reactive T cells. These data support the proposed mode of action whereby host APCs present DCP-001 antigens to the host immune system following intradermal vaccination.

The poster presentation at the upcoming 2019 CIMT (Free CIMT Whitepaper) Annual Meeting will take place on May 21, 2019 at the Rheingoldhalle Congress Center Mainz, Germany.

On May 14, 2019 Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") reported Q1 2019 financial results and provided updates on corporate activities (Press release, Cytori Therapeutics, MAY 14, 2019, View Source [SID1234536262]).

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Q1 2019 net loss was $3.2 million, or $0.18 per share. Operating cash burn for Q1 was approximately $3.3 million. Cytori ended Q1 with approximately $3.9 million of cash and cash equivalents.

Cytori is developing two clinical stage chemotherapy drugs. ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, is the lead product candidate. The Company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) next year based on a successful bioequivalence study completed against the European reference drug. The Company is in the process of completing manufacturing-related activities to support the MAA and is evaluating commercial partners for ATI-0918 with a focus on Europe, which has a current estimated market size of over $120 million.

Cytori is also developing ATI-1123, a patented, albumin-stabilized pegylated liposomal docetaxel. The Company recently received an orphan drug designation from the U.S. FDA for small cell lung cancer and is seeking FDA’s 505(b)(2) new drug application (NDA) and Accelerated Approval pathway.

"The Company’s recent divestiture of its cell therapy businesses allows us to fundamentally reposition and refocus of the Company around our nanotechnology and oncology drug development," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. We intend to begin communicating our plan later in Q2.

Q1 2019 Financial Performance

Q1 2019 operating cash burn was $3.3 million, compared to $4.1 million for Q1 2018.

Q1 2019 product revenues were $0.7 million, compared to $0.7 million for Q1 2018.

Q1 2019 contract revenues were $0.7 million, compared to $0.9 million for Q1 2018.

Q1 2019 Celution consumable utilization grew by approximately 20% as compared to Q1 2018.

Cash and debt principal balances at March 31, 2019 were approximately $3.9 million and $13.0 million, respectively.

Q1 2019 net loss was $3.2 million or $0.18 per share, compared to a net loss of $4.4 million or $0.73 per share for Q1 2018.