On April 12, 2022 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported preliminary total product and service revenue of approximately $31 million for the first quarter (Press release, NanoString Technologies, APR 12, 2022, View Source [SID1234612058]). This unaudited estimate, based on management’s preliminary financial analysis, is lower than the company’s previous guidance for product and service revenue of $34 million to $38 million for the first quarter of 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Preliminary First Quarter Financial Results
•Product and service revenue of $31 million
•GeoMx Digital Spatial Profiler (DSP) revenue of $10 million. GeoMx DSP revenue includes:
◦Instrument revenue of $5 million, 31% year-over-year decline
◦Consumables revenue of $5 million, 78% year-over-year growth, annualized pull-through of approximately $76,000 per installed system
•nCounter revenue, inclusive of all service revenue, of $21 million. nCounter revenue includes:
◦Instrument revenue of $4 million, 11% year-over-year decline
◦Consumables revenue of $13 million, 5% year-over-year decline, annualized pull-through of approximately $48,000 per installed system
◦Service revenue of $4 million, 16% year-over-year growth
•CosMx Spatial Molecular Imager (SMI): Generated orders for more than 15 CosMx SMI systems, bringing total orders to date to more than 35 systems
"Our first quarter revenue fell short of our expectations. After reviewing the preliminary results with the benefit of hindsight, we believe our Q1 revenue was impacted primarily by two factors. First, uneven sales execution resulted in an imbalance between capturing fourth quarter revenue and developing our Q1 2022 funnel of opportunities. Second, we believe this was compounded by the impact of changes made to re-align our expanded commercial team early in the year," said Brad Gray, President and CEO of NanoString. "Customer interest in spatial biology continues to be strong, and we remain confident in our long-term prospects. We’re currently evaluating our financial outlook for the full year and plan to provide an update on our earnings call on May 10th."

Conference Call
The Company plans to host a conference call on Tuesday April 12, at 5:00pm ET to discuss these preliminary results and provide more details. Investors and other interested parties should register for the conference call in advance by visiting View Source Following registration, an email confirmation will be sent that includes dial-in details and unique conference call codes for entry. Registration is open throughout the call but to ensure connection for the full call, registration in advance is recommended. The link to the live webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com.
A replay of the call will be available beginning April 12, 2022 around 7:30pm ET through midnight on April 19, 2022. To access the replay, dial (866) 813-9403 or (929) 458-6194 and reference Conference ID: 508842. The webcast will also be available on the Company’s website for one year following the completion of the call.
The Company plans to release full operating results for first quarter of 2022 after the close of trading on Tuesday, May 10, 2022. Company management will host a conference call beginning at 4:30pm ET to discuss those results and provide updated financial guidance.

On April 12, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies for patients with unmet needs, and Immedica Pharma AB ("Immedica") reported entering a license and supply agreement for Iomab-B, an Antibody Radiation Conjugate comprised of apamistamab, a CD45 targeting antibody, and the radioisotope iodine-131 that is being developed for targeted conditioning to facilitate bone marrow transplant (BMT) and other cell and gene therapies (Press release, Immedica Pharma, APR 12, 2022, View Source [SID1234612057]). A pivotal Phase 3 trial, Study of Iomab-B versus Conventional Care in Elderly, Relapsed or Refractory Acute Myeloid Leukemia (SIERRA), of Iomab-B completed patient enrollment in the third quarter of 2021 with topline data expected in the third quarter of 2022. BMT is the only potentially curative treatment option for patients with active, relapsed or refractory acute myeloid leukemia (AML).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sandesh Seth, Actinium’s Chairman and CEO, said, "Immedica has established a strong team and impressive capabilities to commercialize specialty products in Europe, the Middle East and North Africa. Europe and the MENA countries are key commercial markets for Iomab-B, with a large addressable AML patient population and access to a strong BMT community that is highly concentrated with select leading centers performing a majority of the BMT procedures. Despite multiple drug approvals for patients with AML in recent years, curative outcomes and access to potentially curative BMT, are severely lacking, particularly for patients with active, relapsed or refractory disease. We are excited to partner with Immedica to work to bring Iomab-B to patients with AML in Europe, the Middle East and North Africa who may benefit from a potentially curative transplant."

"We are excited about the opportunity to make Iomab-B accessible for patients in Europe, the Middle East and North Africa. It is clear there is a large medical need for these AML patients, which we believe will be addressed by this new innovative treatment. We also look forward to deepening our collaboration with Actinium to bring the best possible support to AML treatment centers and health care professionals in Europe, the Middle East and North Africa", says Anders Edvell, CEO at Immedica.

Under the terms of the agreement, Actinium will receive an upfront payment of $35 million and will be eligible to receive an additional $417 million in regulatory and commercial milestones as well as royalties in the mid-twenty percent range on net sales. Immedica receives commercialization rights in Europe and MENA countries. Actinium retains all rights related to Iomab-B in the United States and the rest of the world, and will be responsible for certain clinical and regulatory activities and the manufacturing of Iomab-B.

Shadow Lake Group (SLG) served as the advisor to Immedica.

About Iomab-B

Iomab-B (I-131 apamistamab), via the monoclonal antibody apamistamab, targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and bone marrow stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once attached to its target cells emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Iomab-B may avoid the side effects of non-targeted chemotherapy and external radiation on most healthy tissues while effectively killing the patient’s cancer (induction) and marrow cells (myeloablation) including those in bone marrow niches due to the "crossfire" effect enabled by the I-131 radioisotope.

Iomab-B was licensed from the Fred Hutchinson Cancer Research Center where it was studied in nearly 300 patients, in multiple clinical trials in 6 blood cancer indications. Iomab-B is being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with active, relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above.. If granted approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially more efficacious manner and with a more beneficial safety profile than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B has been granted Orphan Drug Designation from the U.S. FDA and the European Medicines Agency (EMA). Iomab-B is covered by patents having terms extending to at least 2036/2037 in Europe and the US. In addition, Actinium received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.

About the SIERRA Phase 3 Trial

The SIERRA trial is a 150-patient, randomized clinical trial, studying Iomab-B compared to physician’s choice of salvage therapy in patients with active, relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial completed enrollment in the third quarter of 2021 with the last patient receiving a BMT in the fourth quarter of 2021. Topline data from the SIERRA trial is expected in the third quarter of 2022. In SIERRA, patients receiving Iomab-B, those achieving a remission after salvage therapy or those patients not achieving remission after salvage therapy that crossed over to receive Iomab-B were offered a BMT, which is the only treatment option with curative potential for patients with active r/r AML. The SIERRA trial is the only randomized Phase 3 trial to offer BMT to this patient population. The control arm of SIERRA included over 20 single agents or combination treatment options based on physician’s choice, including salvage chemotherapy and recently approved targeted agents including Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors as there is no standard of care for this patient population. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada.

On April 12, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, reported that three presentations (one oral and two posters) further supporting the potential of its novel vaccine development capabilities and delivery platforms to develop transformational therapeutic cancer vaccines at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Gritstone Oncology, APR 12, 2022, View Source [SID1234612056]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The collective data we presented at AACR (Free AACR Whitepaper) reinforce our expertise in designing and delivering potent vaccines, and support the optimization of antigen cassette design, dose and vaccine regimen as key tools to induce differentiated immune response," said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. "Vaccines targeting neoantigens identified from common tumor driver mutations are of increasing interest, and the presentation on our ‘off-the-shelf’ candidate for KRAS-specific mutations, SLATE-KRAS, demonstrates our ability to both accurately define those targets and engineer the cassette and vaccine to optimize immune response based on those specific mutations. Early signals from our ongoing Phase 2 study presented at AACR (Free AACR Whitepaper) support the potential of SLATE-KRAS to drive stronger CD8+ T cell responses to mutant KRAS than our original candidate, SLATE v1. We look forward to further demonstrating the value of SLATE as evidence of clinical benefit builds."

Oral Presentation: Optimization of shared neoantigen vaccine design to increase vaccine potency: From bench to bedside and back
Presenter: Christine D Palmer, PhD
Key Highlights:

SLATE v1* was well-tolerated and demonstrated a favorable safety profile in all subjects dosed (n=26). Greatest activity was seen in six (6) NSCLC patients with KRASmut G12C mutations.
Gritstone subsequently developed a second, optimized product candidate (SLATE-KRAS) that exclusively includes epitopes from mutated KRAS.
SLATE-KRAS is being evaluated in the Phase 2 portion of a Phase 1/2 trial (NCT03953235), with initial data expected in the second half of 2022.
*SLATE v1 was administered in combination with Opdivo (nivolumab) and subcutaneous anti-CTLA-4 antibody Yervoy (ipilimumab). Opdivo and Yervoy are trademarks of Bristol-Myers Squibb Company.

Additional presentations at AACR (Free AACR Whitepaper) further elucidated the correlation between patient survival and circulating tumor DNA (ctDNA) in solid tumors (relevant to the company’s individualized vaccine program, GRANITE) and detailed a dose-response analysis, the results of which further support the dose-sparing potential of the company’s novel vector which is it utilizing in both oncology and infectious disease, self-amplifying mRNA (samRNA).

Karin Jooss, Ph.D., Executive Vice President, and Head of R&D added, "Clinical data from SLATE and GRANITE characterizing the optimal dosing regimen for our novel samRNA vector demonstrate more robust immune responses at lower doses, further supporting the overall potency and dose sparing potential of samRNA. The collective data we presented at AACR (Free AACR Whitepaper) has readthrough across our pipeline programs in both oncology and infectious disease, and further demonstrates Gritstone’s leadership in the field of neoantigen vaccines."

Poster Presentation: Comprehensive ctDNA monitoring provides early signal of clinical benefit with a novel personalized neoantigen directed immunotherapy for late-stage cancer patients
Presenter: Matthew Davis, PhD
Key Highlights:

Majority of neoantigens are retained in tumor even after patient receives treatment
ctDNA longitudinal monitoring enables real-time assessment of response/resistance
Molecular response elicited in four (4) of nine (9) treated subjects that correlated with prolonged progression-free survival and overall survival support clinical benefit of GRANITE in patients with advanced MSS-CRC
Poster Presentation: Lower doses of self-amplifying mRNA drive superior neoantigen-specific CD8+ T cell responses in cancer patients versus high doses
Presenter: Amy Rappaport, PhD
Key Highlights:

samRNA demonstrated a favorable safety profile at all 3 dose levels, with no evidence of increasing reactogenicity with sequential doses
Lower dose samRNA (30 μg) increased T cell and humoral responses following a ChAd prime, while higher doses of samRNA (300 μg) only maintained initial response to ChAd
Dose dependent induction of IFN⍺ in cancer patients and nonhuman primates suggest inhibitory impact of early innate immune activation
To view Gritstone’s AACR (Free AACR Whitepaper) presentations, visit ir.gritstonebio.com/investors/events.

About SLATE
Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens, or TSNA, that are identified by the company using its proprietary Gritstone EDGE artificial intelligence platform and tumor HLA peptide sequencing. SLATE, Gritstone’s "off-the-shelf" immunotherapy program, uses a priming adenoviral vector and self-amplifying mRNA vector to deliver a cassette of shared TSNA, representing mutated gene sequences that are found in multiple patients (such as KRAS mutations). SLATE is being evaluated in combination with immune checkpoint blockade in the Phase 2 portion of its clinical study (NCT03953235). Along with the candidates developed to date, SLATE represents the potential to develop a suite of "off-the-shelf" product candidates that target tumor-specific mutations across a number of patient populations and cancer types.

On April 12, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported financial results and corporate updates for the fiscal year ended 31 December 2021 (Press release, Evotec, APR 12, 2022, View Source [SID1234612053]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FINANCIALS REFLECT GREAT PERFORMANCE

Group revenues significantly exceeded the revenue target, up 23% to € 618.0 m (+27% like for like, excluding portfolio and fx effects (2020: € 500.9 m))

Base business up 18% (20% adjusted for Sanofi payment in Q1 2020)

Adjusted Group EBITDA in line with guidance at € 107.3 m, up 1% (2020: € 106.7 m); like-for-like growth up 18%

Unpartnered R&D expenses of € 58.1 m (2020: € 46.4 m up 25%)

Very strong liquidity position with € 858.2 m in cash

GREAT PROGRESS ACROSS ALL "BUILDING BLOCKS" OF ACTION PLAN 2025

Multiple new and extended integrated drug discovery, development, and manufacturing alliances

Important clinical trial initiations and significant progress in co-owned pipeline

Excellent progress in iPSC and protein degradation collaborations with Bristol Myers Squibb; Opt-in for EVT8683 and start of clinical development

New EVT Innovate partnerships e.g. in heart failure, kidney disease, RNA-based drug discovery, oncology, etc.

Acceleration & initiation of innovative platforms, tools & technologies – EVOcells, EVOpanOmics, EVOpanHunter, E.INVENT.AI, E.SOLVE, E.RNA, etc.

Launch of three new BRIDGEs, the pandemic preparedness initiative PRROTECT as well as E.MPD, the largest and highest quality molecular patient database (after period-end)

Excellent progress within operational venturing strategy, including Exscientia IPO on NASDAQ

CORPORATE HIGHLIGHTS

Secondary listing on NASDAQ with public offering raising gross proceeds of $ 500 m

Opening of J.POD(R) Redmond, WA (US); initiation of J.POD(R) Toulouse, France (EU)

Expansion of footprint with the acquisition of land and buildings of Verona (Italy) site from GlaxoSmithKline SpA, now "Campus Levi-Montalcini"; Sustainable expansion of "Dorothy Crowfoot Hodgkin Campus" in Abingdon (UK); Relocation of Munich site to Campus Neuried (after period-end)

Dr Matthias Evers joins Evotec as Chief Business Officer (effective 1st May 2022)

FINANCIAL GUIDANCE 2022 – CONTINUED STRONG GROWTH

Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58.1 m)

Adjusted Group EBITDA expected to be in the range of € 105 – 120 m (€ 95 – 110 m at constant exchange rates) (2021: € 107.3 m)

Revenues in the segments consist of revenues from contracts with customers without revenues from recharges as those are not of importance for the management to assess the economic situation of the segments.

Thereof unpartnered R&D expenses of € 58.1 m in 2021 and € 46.4 m in 2020

Adjusted EBITDA before contingent consideration and excluding impairments on goodwill, other intangible and tangible assets as well as the total non-operating result

In 2021, Evotec’s group revenues increased by 23% to € 618.0 m (+27% like for like, excluding portfolio and fx effects) (2020: € 500.9 m), in a market that saw disruptions caused by the COVID-19 pandemic. Like-for-like growth is adjusted for the end of the Sanofi payment after Q1 2020 (€ (8.6) m) and negative foreign exchange effects (€ (9.2) m) in 2021. The positive development was mainly due to the continued robust performance of the base business in all areas as well as higher milestone payments. Due to great progress within both existing and new partnerships (e.g. with Bristol Myers Squibb ("BMS") in neuroscience and with Takeda in RNA-targeting small molecules), revenues from upfront, milestone and licence payments were significantly higher than in the previous year (2020: € 30.1 m) at € 61.3 m. Additionally, fiscal year 2021 benefited from an increased revenue contribution by Just – Evotec Biologics of € 53.6 m (2020: € 41.1 m).

In 2021, Evotec substantially increased its unpartnered R&D expenses of € 58.1 m (2020: € 46.4 m) in order to further accelerate the development of its efficiency and precision medicine platforms as well as the development of new first-in-class drug candidates. Its partnered R&D expenses declined to € 14.1 m (2020: € 17.5 m). "Partnered" are funded projects and are mainly run at the ID Lyon site, which was acquired in 2018.

In 2021, the group’s selling, general and administrative ("SG&A") expenses increased by 37% to € 105.4 m (2020: € 77.2 m), mainly as a result of an increase of the headcount in preparation for future growth as well as NASDAQ listing-related expenses for consulting and legal services as well as higher insurance premiums. One-off expenses for the US listing and other strategic activities amounted to approximately € 1.7 m.

Adjusted Group EBITDA increased to € 107.3 m in 2021 (+1% and + 18% like for like) (2020: € 106.6 m), despite significant expenditures into R&D as well as higher COGS and SG&A expenses ahead of the

manufacturing start at J.POD(R) Redmond, WA (US). The increase was mainly due to higher base business, increasing revenues from milestone payments, and favourable R&D tax credits in Italy and France.

Evotec recorded an operating result for 2021 of € 41.0 m (2020: € 48.5 m), due to the reasons mentioned above as well as higher depreciations after completion of the J.POD(R) facility in Redmond, WA (US). With € 215.5 m, the Company’s net income was significantly higher than in the previous year (2020: € 6.3 m). This increase was mainly due to an adjustment to the fair value of Evotec’s stake in Exscientia Ltd. following Exscientia’s IPO in the US.

With the liquidity increase following Evotec’s own public offering on NASDAQ, the net debt ratio at 31 December 2021 (excl. IFRS16) improved to a net cash position of (negative) 5.5x adjusted Group EBITDA (2020: (negative) 1.5x adjusted Group EBITDA) with a net cash position of € 494.3 m and a significantly increased equity ratio of 61.6% (2020: 49.4%).

STRONG PERFORMANCE ACROSS ALL BUSINESS SEGMENTS

EVT Innovate was characterised in 2021 by multiple important clinical trial initiations, an acceleration of the milestone income from its strategic partnerships (e.g. iPSC neuroscience and targeted protein degradation collaborations with BMS as well as the signing of multiple new partnerships e.g., with Takeda in RNA-based drug discovery, with Chinook Therapeutics in chronic kidney diseases, and with Medical Center Hamburg-Eppendorf in heart failure.

In the course of 2021, notable achievements were obtained within Evotec’s strategic partnerships with BMS. BMS exercised a licensing option for EVT8683 and moved the compound into a first clinical Phase I trial shortly thereafter. The opt-in decision by BMS led to a payment of $ 20 m to Evotec. Moreover, the inclusion of a new cell type and additional programme designations triggered payments of more than $ 50 m to Evotec.

In 2021 we also saw several other pipeline assets added to the list of drug candidates in clinical trials: In January 2021, the chikungunya virus antibody EVT894 entered Phase I of clinical development. The immuno-oncology project A2a receptor antagonist in cooperation with Exscientia reached Phase I. Also, Evotec’s oncology agent EVT801 developed in cooperation with Kazia Therapeutics entered clinical development.

In autumn 2021 Bayer’s drug candidate eliapixant (BAY1817080) showed positive Phase IIb results in refractory chronic cough. However, at the beginning of February of 2022 (after period-end), Bayer informed Evotec about its decision to discontinue the development of the investigational P2X3 receptor antagonist eliapixant (BAY1817080). As a consequence of Bayer’s decision, Evotec has the possibility to regain the rights to all P2X3 assets. The Company will evaluate the underlying data and all options.

In 2021, Evotec’s academic BRIDGE model was accelerated through the launch of three new BRIDGE partnerships. In April and May of 2021, beLAB2122, beLAB1407 were launched, each backed by Bristol Myers Squibb with a total funding volume of $ 20 m each. June 2021 saw the launch of Danube Labs, a BRIDGE partnership with CEBINA GmbH to identify and develop academic projects from Central and Eastern Europe into mature therapeutic product development opportunities. The Company made a new investment in the promising Biotech company OxVax that is based on research from Oxford University, and participated in several financing rounds and successful spin-offs, such as Topas Therapeutics, Celmatix and CureXsys. In October of 2021, Exscientia Ltd., in which Evotec has a significant stake, successfully completed an IPO on NASDAQ.

Evotec also made significant progress towards building the globally leading precision medicine platform by accelerating and initiating innovative platforms, tools, and technologies such as EVOcells, EVOpanOmics, EVOpanHunter, E.INVENT.AI, E.SOLVE, E.RNA, etc. At the start of 2022, to leverage the power of molecular data, Evotec launched its molecular patient database (E.MPD). E.MPD is one of the largest and highest quality molecular databases globally.

The EVT Execute segment continued to demonstrate strong progress in 2021 with new and extended alliances. In 2021, Evotec was involved in 842 alliances and recorded a repeat business of 91%. Evotec signed new and extended existing partnerships and alliances, e.g. with Abivax, Annexon, Awakn, 1st Biotherapeutics, Bicycle Therapeutics, EQRx, Evommune, Interline, Related Sciences, Takeda. Just – Evotec Biologics continued its strong growth by continuing the collaboration with the US Department of Defense, and introducing the humanoid antibody library J.HAL℠ to the market.

J.POD(R) REDMOND, WA (US) OPEN FOR BUSINESS, J.POD(R) TOULOUSE, FRANCE (EU) INITIATED

In August 2021, Evotec opened its late-stage clinical and commercial biologics current Good Manufacturing Practice ("cGMP") manufacturing facility, J.POD(R) Redmond WA, (US). The innovative 130,000 square foot cGMP biomanufacturing facility was designed with improved environmental sustainability and a significant compressed construction time compared to traditional biologics manufacturing. Additionally, the design and planning of a second J.POD(R) facility in Europe has been initiated. The build-up of J.POD(R) Toulouse, France (EU) will be supported by the French government, the Occitanie Region, Bpifrance, the Haute-Garonne prefecture as well as the Toulouse Métropole. J.POD(R) Toulouse, France (EU) is expected to be fully operational in 2024.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "2021 was another very successful year for Evotec, making it the tenth consecutive year of double-digit growth. Our profitable base business gives us the opportunity to reinvest returns into our data-driven platforms, to enter a sustainable growth pattern. Based on our core principles of leveraging data, artificial intelligence and human disease models to improve probabilities of success, Evotec is in an ideal position to drive and thrive as the industry paradigm shifts to effective precision medicines of the future."

FINANCIAL GUIDANCE 2022 – ACCELERATING SUSTAINABLE GROWTH

In 2022, Evotec expects Group revenues to grow in a range of € 700 – 720 m. At unchanged exchange rates compared to 2021, this range is € 690 – 710 m. This assumption is based on current orders on hand, foreseeable new contracts and the extension of contracts as well as prospective milestone payments as well as the current status of the main foreign currency exchange rates (especially US$; GBP). Furthermore, the forecast takes into account – as far as possible – the current global uncertainties related to the COVID-19 pandemic.

Evotec expects to achieve a stable adjusted Group EBITDA in the range of € 105 – 120 m. This projection takes account of increasing expenses for promising R&D projects, continued expansion of capacity and adoption of organisation structures to ensure sustainable growth, the ramp-up of the Just – Evotec Biologics business via investments, the further expansion of the J.POD(R) capacities in the US and the construction of a second J.POD(R) in Toulouse, France.

Evotec’s activities are all related to research and development ("R&D"). Aside from the partnered and funded R&D, Evotec will continue to strongly invest in its own unpartnered R&D to further expand its long-term and sustainable pipeline of first-in-class projects and platforms. Evotec expects unpartnered R&D investments in this area between € 70 and 80 m in 2022. Revenues, Unpartnered R&D expenses, and adjusted EBITDA remain the financial key performance indicators of the Evotec Group.Download

The full annual report 2021 as well as the sustainability report 2021 will be available for download on April 26.

Webcast/Conference Call

The Company is holding a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

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 homepage www.evotec.com shortly before the event.

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

On April 12, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported the presentation of preclinical data for DCC-3116, the Company’s first-in-class ULK kinase inhibitor, in combination with KRASG12C inhibitors in non-small cell lung cancer (NSCLC) models at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans, Louisiana (Press release, Deciphera Pharmaceuticals, APR 12, 2022, View Source [SID1234612052]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Autophagy is recognized as a mechanism of drug resistance in cancer and an exciting target for drug development. The combination of a KRASG12C inhibitor with DCC-3116, a selective and potent inhibitor of the ULK1/2 protein kinases that are key autophagy regulators, has the potential to promote deeper and more durable clinical responses than a KRASG12C inhibitor alone," said Martin McMahon, Ph.D., Cumming-Presidential Chair of Cancer Biology in the Dept. of Dermatology, Senior Director for Preclinical Translation and Co-Leader of the Experimental Therapeutics Program in the Huntsman Cancer Institute. "The data I presented today provides strong preclinical rationale for this approach and underscores the importance of autophagy inhibition in the treatment of cancer, demonstrating a compelling rationale to study DCC-3116 in combination with KRASG12C inhibitors in clinical trials in non-small cell lung cancer patients."

Results from the preclinical studies, presented in an oral presentation titled "DCC-3116, a first-in-class selective inhibitor of ULK1/2 kinases and autophagy, combines with the KRASG12C inhibitor sotorasib resulting in tumor regression in NSCLC xenograft models" are summarized below. The presentation is available on-demand via the meeting’s website and on the Company’s website at www.deciphera.com/presentations-publications.

Summary of Preclinical Data and Findings

Results from the preclinical studies showed that KRASG12C inhibitors, sotorasib and adagrasib, activate ULK-mediated autophagy as an adaptive treatment resistance mechanism. DCC-3116 in combination with sotorasib and with adagrasib inhibited ULK kinase activation and the resulting autophagic flux in a KRASG12C mutated NSCLC cell line. Results demonstrated that DCC-3116 in combination with sotorasib and with adagrasib translated to deeper and longer tumor regressions in vivo. The study also demonstrated that DCC-3116 in combination with sotorasib outperformed both single agent sotorasib and the combination of sotorasib and chloroquine, a nonspecific lysosomal inhibitor of autophagy.

Results of the preclinical studies were as follows:

Treatment of mutant KRASG12C NSCLC cell lines with KRASG12C inhibitors, sotorasib and adagrasib, induced autophagy via activation of ULK1/2 kinases as measured by an increase in ULK-mediated phosphorylation of the key ULK autophagy substrate ATG13 and resulting increase in autophagic flux.
In mutant KRASG12C NSCLC cell lines, DCC-3116 inhibited ULK kinase activation by both sotorasib and adagrasib, as measured by a decrease in phosphorylated ATG13 and resulting autophagic flux.
In the H358 KRASG12C NSCLC xenograft model, the combination of DCC-3116 and sotorasib resulted in deeper and longer tumor regressions compared to all single agent sotorasib cohorts.
In the Calu-1 KRASG12C NSCLC xenograft model, the combination of DCC-3116 and sotorasib resulted in tumor regressions and outperformed both single agent sotorasib and the combination of sotorasib and chloroquine.
In the LU11554 KRASG12C NSCLC patient derived xenograft model, the efficacy for the combination of DCC-3116 with sotorasib or with adagrasib increased tumor growth inhibition compared to sotorasib or adagrasib alone.
DCC-3116 is currently being investigated in a Phase 1, multicenter, open-label, first-in-human study designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of DCC-3116 as a single agent and in combination with trametinib, an FDA approved MEK inhibitor, in patients with advanced or metastatic tumors with a mutant RAS or RAF gene. Initial data from the single agent dose escalation portion of the Phase 1 study is expected in the second half of 2022. The Company expects to initiate Phase 1 study dose escalation cohorts in the second half of 2022 in combination with trametinib in patients with selected mutations in advanced or metastatic pancreatic ductal adenocarcinoma, NSCLC, colorectal cancer, and melanoma. Planning is underway to add a combination with a KRASG12C inhibitor in NSCLC to the ongoing Phase 1 study, subject to feedback from regulatory authorities.

About DCC-3116

DCC-3116 is an investigational, orally administered, potent, and highly selective switch-control inhibitor designed to inhibit cancer autophagy, a key tumor survival mechanism in cancer cells, by inhibiting the ULK1/2 kinases, which have been shown to be the initiating factors that activates autophagy. DCC-3116 is currently being studied in a Phase 1, multicenter, open-label, first-in-human study as a single agent and in combination with trametinib, an FDA approved MEK inhibitor, in patients with advanced or metastatic tumors with a mutant RAS or RAF gene (NCT04892017).