On August 11, 2022 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the quarter ended June 30, 2022 and provided recent business highlights (Press release, Shattuck Labs, AUG 11, 2022, View Source [SID1234618082]).

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"We have made significant progress throughout the second quarter, including dosing patients in our Phase 1 clinical trial of SL-172154 in AML and HR-MDS and advancing SL-172154 in our clinical trial in platinum-resistant ovarian cancer," said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck. "As we look ahead to the second half of this year, we look forward to beginning to enroll patients at immunologically active dose levels of SL-172154 in combination with liposomal doxorubicin for patients with advanced platinum-resistant ovarian cancer and with azacitidine for patients with AML and HR-MDS. We also continue to make excellent progress advancing our preclinical pipeline from our ARC and GADLEN platforms, and we expect to nominate the next clinical product candidate by the end of this year."

Second Quarter 2022 Recent Business Highlights and Other Recent Developments

ARC Clinical-Stage Pipeline and Preclinical Pipeline

SL-172154 (SIRPα-Fc-CD40L)

Continued Enrollment of SL-172154 Phase 1 Monotherapy Dose-Escalation Clinical Trial in Platinum-Resistant Ovarian Cancer: This open-label, multi-center, dose-escalation clinical trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with advanced platinum-resistant ovarian cancer. To date, Shattuck has dose escalated to the anticipated top dose level of 10.0 mg/kg. Most patients at both the 3.0 mg/kg and 10.0 mg/kg dose levels have experienced grade 2 infusion related reactions, which did not lead to any treatment discontinuations. In one of five patients treated at the 10.0 mg/kg dose level, we observed a dose limiting toxicity of alanine transaminase increase. Preliminary data suggest that extending the duration of infusion may reduce the incidence of infusion related reactions. We are currently enrolling additional patients at 3.0 mg/kg with an extended infusion time. To date, we have observed no evidence of destructive anemia in any patient treated. We have observed full receptor occupancy and receptor saturation of CD40 and CD47 at the 3.0 mg/kg dose level and data indicate that both serum cytokine elevations and margination of CD40+ B cells and monocytes have achieved a maximal plateau at doses of 3.0 mg/kg and 10.0 mg/kg. Dose-escalation data from the trial are expected in the first half of 2023.
Combination Trial of SL-172154 with Liposomal Doxorubicin Expected to Begin in the Third Quarter of 2022: This trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamics effects of SL-172154 in combination with liposomal doxorubicin in patients with advanced platinum-resistant ovarian cancer and is anticipated to begin enrollment in the third quarter of 2022. Our starting dose of SL-172154 in this trial is 3.0 mg/kg. Initial combination data from the trial are expected in the first half of 2023.
Enrollment Continues in SL-172154 Phase 1A/B Clinical Trial in AML and HR-MDS: The trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 as both monotherapy and in combination. Our starting dose of SL-172154 in the monotherapy portion of this clinical trial is 1.0 mg/kg. In AML, SL-172154 will be evaluated in combination with both azacitidine and venetoclax. In both HR-MDS and TP53 mutant AML, SL-172154 will be combined with azacitidine. We plan to dose escalate as both monotherapy and in combination in a parallel staggered manner. Initial dose-escalation and combination data from the trial are expected in the first half of 2023.
Provided Clinical Data for Intratumorally Administered SL-172154 in Phase 1 Clinical Trial in Squamous Cell Carcinoma of the Head and Neck (HNSCC) or Skin (CSCC): As of the data cut-off date of April 8, 2022, five patients with cancer, four with CSCC and one with HNSCC, were treated with intratumoral administration of SL-172154 across two dose levels, 0.003 and 0.01 mg. All patients had prior anticancer surgery, four out of five patients had prior radiotherapy, and all patients had prior systemic therapy, with a median of two prior lines. SL-172154 was well tolerated at the two dose levels studied with no dose-limiting toxicities reported, and no significant safety signals were noted. An unconfirmed partial response was observed in a patient with CSCC who experienced a 75 percent reduction in the target lesion, and stable disease was observed in an additional CSCC patient. Increases in CD80, a marker of CD40 activation, have been observed in on-treatment tumor biopsies. Based on the totality of the safety and biomarker data collected to date in the ongoing Phase 1 clinical trial in ovarian cancer patients, Shattuck has decided to focus on developing SL-172154 as an intravenously administered product candidate.
SL-279252 (PD1-Fc-OX40L)

Continued Enrollment of SL-279252 Phase 1 Dose-Escalation Clinical Trial in Advanced Solid Tumors: Enrollment of patients with primarily PD-L1 selected tumors continues in the Phase 1 open-label, multi-center, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity and pharmacodynamic effects of SL-279252 in patients with advanced solid tumors and lymphoma. Top-line data from the Phase 1 trial are anticipated in the second half of 2022.
Preclinical

Presented Preclinical Development of Gamma Delta T Cell Engager, or GADLEN, platform at the 3rd Gamma Delta T Therapies Summit in July 2022: Data were presented demonstrating preclinical proof of concept for Shattuck’s butyrophilin heterodimer-based gamma delta T cell engager platform. Data from CD19, CD20, and B7-H3-targeted GADLEN constructs demonstrated the newly described role of co-stimulation during Vg9d2 T cell activation and tumor cell killing. In vivo proof-of-concept data was also presented establishing the ability of the CD20-GADLEN to activate human Vg9d2 T cells to target and serially deplete CD20-expressing human B-cells in a dose-dependent, and highly specific, manner.
Presented Preclinical Development of SL-9258 at the PEGS Conference in May of 2022 and Published the Associated Preclinical Manuscript in the Journal of Immunology in July 2022: SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist, was shown to induce potent anti-tumor immunity in preclinical mouse models of checkpoint primary and acquired resistance, both alone and when combined with anti-PD1 or anti-PDL1, through the simultaneous blockade of the TIGIT checkpoint pathway and broad immune activation of T, NK, and myeloid cells through the TNF-costimulatory ligand known as LIGHT.
Clinical Pipeline Product Candidate to be Selected in 2022: As Shattuck looks to advance its preclinical pipeline, a new clinical product candidate from our ARC or GADLEN platform is anticipated to be announced in the second half of 2022.
Upcoming Events

Citi’s 17th Annual BioPharma Conference: Management will participate in investor one-on-one meetings and a fireside chat at Citi’s 17th Annual BioPharma Conference from September 7-8, 2022.
H.C. Wainwright 24th Annual Global Investment Conference: Management will participate in investor one-on-one meetings and give a corporate presentation during the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022.
Live and archived audio webcasts of both the fireside chat and presentation will be available by visiting the Events & Presentations section of the Company’s website.
Second Quarter 2022 Financial Results

Cash Position: As of June 30, 2022, cash and cash equivalents and short-term investments were $214.2 million, as compared to $268.8 million as of December 31, 2021.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2022 were $23.0 million, as compared to $14.9 million for the quarter ended June 30, 2021. This increase was primarily driven by increases in process development costs and manufacturing of trial materials to support clinical development of SL-172154, lab supplies, and personnel-related costs.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2022 were $4.8 million, as compared to $5.4 million for the quarter ended June 30, 2021. This decrease was primarily driven by decreases in personnel-related and other operating costs.
Net Loss: Net loss was $27.4 million for the quarter ended June 30, 2022, or $0.65 per basic and diluted share, as compared to a net loss of $23.6 million for the quarter ended June 30, 2021, or $0.56 per basic and diluted share.
2022 Financial Guidance
Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2024, beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. This cash runway guidance is based on the Company’s current operational plans and excludes any addition funding that may be received, proceeds from business development transactions, or additional costs associated with clinical development activities that may be undertaken.

About SL-172154
SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Multiple Phase 1 clinical trials are ongoing for patients with advanced platinum-resistant ovarian cancer (NCT04406623, NCT05483933) and patients with AML and HR-MDS (NCT05275439).

About SL-279252
SL-279252 (PD1-Fc-OX40L) is an investigational ARC fusion protein designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 receptor in patients with advanced cancers. A Phase 1 trial in patients with solid tumors and lymphoma is ongoing (NCT03894618).

On August 10, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, reported that financial results for the second quarter of 2022 (Press release, Aadi Bioscience, AUG 10, 2022, View Source [SID1234618873]).

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"We continue to progress in key areas after our first full quarter following FYARRO’s launch. We are excited to see FYARRO reaching more patients through continued account adoption and steady growth in overall sales," said Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. "We are also encouraged by the progress on our tumor agnostic PRECISION 1 trial targeting TSC1 and TSC2 inactivating alterations which continues to ramp up, with activation of additional clinical trial sites and patient enrollment. We anticipate providing preliminary data on a meaningful number of patients in this trial during the first half of 2023. In addition, we continue to evaluate strategies for new clinical indications of nab-sirolimus either as single agent or in combination with other targeted therapies with the potential for new programs as early as 2023."

Corporate Updates for the Second Quarter 2022

FYARRO net product sales for the three months ended June 30, 2022 were $3.4 million, the first full quarter of sales following the product launch late in the first quarter.
A product-specific permanent J-code (J9331) for FYARRO from Centers for Medicare and Medicaid Services (CMS) became effective on July 1, 2022. This code is expected to further facilitate reimbursement for FYARRO.
The Company announced its addition to both the U.S. small cap Russell 2000 Index and broad-market Russell 3000 Index at the conclusion of the 2022 Russell indexes annual reconstitution, which captures the 4,000 largest U.S. stocks, ranking them by total market capitalization.
Partnerships with prominent next generation sequencing (NGS) providers and leaders in genomic testing and profiling was announced during the quarter, which included Foundation Medicine, Tempus and others. The Company is leveraging these partnerships to expedite patient identification and recruitment for the ongoing PRECISION 1 trial of nab-sirolimus in patients harboring tumors with inactivating alterations in TSC1 or TSC2 genes, and is making significant progress toward opening the trial in at least 20 major cancer centers and upward of 120 treatment sites in the U.S. by the end of 2022.
A poster presentation entitled, "nab-Sirolimus for patients with advanced malignant PEComa with or without prior mTOR inhibitors: Biomarker results from AMPECT and an expanded access program" was presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data included exploratory biomarker results reported from the final analysis of mTOR inhibitor-naïve advanced malignant PEComa patients treated with nab-sirolimus in the Advanced Malignant PEComa Trial (AMPECT) trial as well as an analysis of prior mTOR inhibitor exposed advanced malignant PEComa patients treated with nab-sirolimus in the Expanded Access Program (EAP) through June 2021. Findings from both the AMPECT study and the EAP showed greater clinical benefit in patients with TSC1 or TSC2 inactivating alterations who received nab-sirolimus compared to all evaluable patients, regardless of prior mTOR inhibitor exposure.
The Company sponsored a poster at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) which indicated the incidence of advanced cancer patients carrying TSC1 or TSC2 inactivating gene alterations numbered approximately 12,000 annually in the US, thus potentially rendering these patients eligible for nab-sirolimus therapy.
Second Quarter 2022 Financial Results

Cash and cash equivalents on June 30, 2022 were $118.7 million, compared to $149.0 million as of December 31, 2021. Based on current plans, the Company expects cash and cash equivalents to fund operations into 2024.
Total revenue for the quarter ended June 30, 2022 was $3.4 million resulting from sales of FYARRO.
In the second quarter of 2022, the Company recorded a non-cash impairment charge of $3.7 million to write-off the value of an intangible asset related to the Gossamer license agreement with the Company’s predecessor, Aerpio.
Net loss for the three months ended June 30, 2022 was $18.3 million compared to $1.5 million for the three months ended June 30, 2021.
Conference Call Information

The Aadi management team is hosting a conference call and webcast today at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the second quarter of 2022.

Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Biosciences website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

About FYARRO

FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

About the PRECISION 1 Trial

The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic pivotal study, of nab-sirolimus designed as a basket trial that will evaluate approximately 120 adult and adolescent patients with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial will have two independent arms of 60 patients each to separately evaluate patients with either TSC1 or TSC2 inactivating alterations. Aadi has received Fast Track designation to evaluate nab-sirolimus in this indication from the FDA. The first patient in the PRECISION 1 trial was dosed in March 2022.

On August 10, 2022 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the second quarter and first half of 2022 (Press release, Epigenomics, AUG 10, 2022, View Source [SID1234618423]).

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Key figures

Total revenue increased slightly from EUR 223 thousand to EUR 241 thousand in the first half of 2022 compared with the same period of the previous year.
Research and development costs increased from EUR 1,545 thousand in the first six months of 2021 to EUR 3,140 thousand in reporting period. The increase is due to investment in the "Next-Gen" product and increased enrollment of the post approval study compared to the reduced Covid-19 impacted enrollment of 2021.
Sales, General and Administrative expenses increased from EUR 3,021 thousand to EUR 3,582 thousand.
EBITDA (before share-based payment expenses) amounted to EUR -3,677 thousand in the reporting period, compared with EUR -3,165 thousand in the same period of the previous year.
The net loss for the period was EUR -3,957 thousand (H1 2021: EUR -3,528 thousand); the loss per share decreased from EUR 0.41 to EUR 0.24 compared to the prior-year period.
Cash consumption increased to EUR 6,283 thousand in the first half of 2022, compared with EUR 4,214 thousand in the same period of the previous year.
As of June 30, 2022, the Company had cash and cash equivalents of EUR 18,043 thousand (December 31, 2021: EUR 23,049 thousand).
Epigenomics AG assumes that given the planned financial development, a cumulative loss of more than half of the nominal share capital will occur in the near future. The Company will, upon occurrence of the loss, make a corresponding publication and call a shareholders meeting pursuant to Section 92 par. 1 German Stock Corporation Act ("Aktiengesetz") to which the loss will be notified.
Operational developments

Epigenomics’ Executive Board remains confident that Epi proColon "Next-Gen" will meet the Centers for Medicare and Medicaid Services’ (CMS) reimbursement criteria (74% sensitivity and 90% specificity) and therefore filled a pre-submission with FDA for the clinical trial this spring. Patient enrollment is on-track to begin this summer.
The Company is also continuing its efforts to achieve CMS reimbursement for the current Epi proColon test via legislation. Sponsorship of the bill has increased to a bipartisan representation of 68 members of Congress. However, evaluating the prospects for success remains difficult.
In order to achieve the goal of FDA approval and reimbursement for "Next-Gen", the Company will need to raise additional capital to complete the trial and supporting activities required for subsequent FDA approval. The Company is actively exploring all methods to attract the necessary capital to achieve its goals, including a potential listing on an alternative exchange.
Greg Hamilton, CEO of Epigenomics AG: " We are on track to accomplish our "Next-Gen" goals for 2022, specifically, initiation on the clinical trial and presentation of preliminary data. In order to deliver and commercialize "Next-Gen" the Company must raise the necessary capital. We believe that with the release of the preliminary data and the initiation of the study, we will be able to realize the significant market opportunity with "Next-Gen"."

Outlook 2022

Revenue

The Company confirms its outlook for fiscal year 2022 and continues to expect revenue within the range of EUR 0.3 million to EUR 0.8 million.
EBITDA / cash consumption

For EBITDA (before share-based payment expenses), Epigenomics forecasts a range of EUR
-15.0 million to EUR -17.0 million for the current full year 2022. Based on the Company’s 2022 business plan, cash consumption is expected to be in line with the EBITDA forecast (before share-based compensation expenses).
Further information

The interim statement for the first six months 2022 (unaudited) can be found on Epigenomics’ website at: View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed at the following link: View Source

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

On August 10, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported financial results for the second quarter ended June 30, 2022 (Press release, Tracon Pharmaceuticals, AUG 10, 2022, View Source [SID1234618158]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We continue to have robust accrual in the ENVASARC pivotal trial as we have enrolled more than 36 patients and look forward to reporting the interim efficacy analysis on the initial 36 patients in the fourth quarter, after each patient has had two on-study scans." said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Additionally, we await the outcome of the binding arbitration relating to I-Mab’s alleged breaches of the TJ4309 and bispecific antibody agreements, and anticipate completing the TJ4309 Phase 1 trial that permits I-Mab the opportunity to terminate the license for a $9M payment to TRACON. We expect both the arbitration decision and the termination of the TJ4309 license to occur this year."

Recent Corporate Highlights

In June, we announced a registered direct financing of approximately $4.0 million in the aggregate with an accredited institutional healthcare-focused fund, which was completed at market price.

In July, we announced the enrollment of the 36th patient in the ENVASARC Phase 2 pivotal trial at the 600 mg dose of envafolimab.

In August, we announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.

In August, the Independent Data Monitoring Committee (IDMC) recommended the ENVASARC trial proceed as planned following the review of more than three weeks of safety data from more than 20 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.
Expected Key 2022 Milestones

Report the interim safety analysis by the IDMC following the review of more than twelve weeks of safety data from more than 20 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.

Report the interim efficacy analysis by the IDMC following the review of more than twelve weeks of efficacy data from 36 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.

Initiate dosing in the Phase 1/2 clinical trial of envafolimab with our potential best in class CTLA-4 antibody YH001 as well as with doxorubicin chemotherapy.

Report the International Chamber of Commerce (ICC) Arbitration Panel’s (the Tribunal) binding decision in the ongoing arbitration involving the TJ4309 and bispecific antibody agreements with I-Mab Biopharma where we are seeking to recover over $200 million in damages.

Complete the TJ4309 Phase 1 clinical trial permitting I-Mab the opportunity to terminate the TJ4309 license for a $9.0 million payment to TRACON.
Second Quarter 2022 Financial Results

Cash and cash equivalents were $13.6 million at June 30, 2022, compared to $24.1 million at December 31, 2021 and is expected to fund the company into 2023.

Research and development expenses for the second quarter of 2022 were $2.9 million, compared to $3.1 million for the second quarter of 2021.

General and administrative expenses for the second quarter of 2022 were $3.3 million, compared to $6.1 million for the second quarter of 2021. The decrease was primarily attributable to legal expenses incurred in the second quarter of 2021 due to the now stayed lawsuit filed by I-Mab in the Delaware Court of Chancery involving the TJ4309 agreement.

Net loss for the second quarter of 2022 was $6.2 million, compared to $8.9 million for the second quarter of 2021.
Conference Call Details

To access the call by phone, please register using this link and you will be provided with dial in details.

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

About YH001

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

About TRC102

TRC102 (methoxyamine) is a novel small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On August 10, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported its financial results for the first half-year of 2022 (Press release, Evotec, AUG 10, 2022, View Source [SID1234618079]).

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HIGHLIGHTSEVOTEC CONTINUES ITS STRONG ORGANIC REVENUE GROWTH IN ALL BUSINESS AREAS

Group revenues increased by 24% to € 336.9 m (H1 2021: € 271.3 m) driven by strong demand for its base business; like-for-like revenue growth (excluding fx-effects) 19%
Continued strong revenue growth momentum: Total EVT Execute revenues (incl. intersegment revenues) up 26% to € 351.0 m (H1 2021: € 279.5 m); EVT Innovate revenues due to a strong growth in Q2 up 36% to € 78.0 m (H1 2021: € 57.3 m)
Reported adjusted Group EBITDA totalled € 33.6 m (H1 2021: € 36.2 m); excellent Group gross margin increasing by 270 bps to 27.3% excluding Just – Evotec Biologics, which is in its build up phase; lower contribution from milestones, upfronts and licenses as well as continued expenses for capacity expansion; higher energy costs, higher costs along the supply chain and costs related to the acquisition of Rigenerand Srl; negative effects partially offset by positive fx-effects
Other non-operating result of € (89.8) m (H1 2021: € 106.1 m) explained by the non-cash fair value adjustments of the equity investment in publicly listed Exscientia plc.

NEW AND EXTENDED ALLIANCES REFLECT SUCCESS OF GROWTH STRATEGY

Significant operational and scientific step-up of targeted protein degradation alliance with Bristol Myers Squibb ("BMS")
Several new integrated drug discovery collaborations signed, including INDiGO, CMC and DMPK agreements
New collaborations signed, based on unique, data-driven platforms with Almirall (dermatology), Boehringer Ingelheim (iPSC), Eli Lilly (E.MPD), Janssen (TargetAlloMod) and Sernova (iPSC)
Just – Evotec Biologics: Just –Evotec Biologics is currently in its initial build up phase. Strategic investments into disruptive technology platform show good progress – foundation laid for accelerated revenue growth; multiple new development and manufacturing agreements, e.g., among others with Alpine Immune Sciences (after period-end)
Co-owned pipeline projects progressing well, e.g. Phase II start of BAY 2395840 (diabetic neuropathic pain), expansion with JingXin for EVT201, submission for approval in China
Successful expansion of the EVOequity portfolio with new strategic equity stakes in several promising companies such as Centauri, IMIDomics, Sernova and Tubulis
Launch of Aurobac Therapeutics, a joint venture with Boehringer Ingelheim and bioMérieux, to create the next generation of antimicrobials along with actionable diagnostics to fight Antimicrobial Resistance ("AMR")

CORPORATE

Effective May 2022, Dr Matthias Evers joins Management Board as Chief Business Officer ("CBO"), responsible for business development, digital technology and strategy
Signing of definitive agreement to acquire the cell technology company Rigenerand Srl, a leader in the field of cGMP manufacturing of cell therapies, which will operate as Evotec (Modena) Srl
Annual General Meeting 2022: Approval of all proposed agenda items; Camilla Macapili Languille elected to the Supervisory Board

BUSINESS OUTLOOK FOR FULL-YEAR 2022 REFINED AND MID-TERM TARGETS 2025 CONFIRMED

Group revenues now expected to be in a range of € 715 – 735 m versus € 700 – 720 m previously (unchanged at € 690 – 710 m at constant exchange rates) (2021: € 618 m)
Adjusted Group EBITDA expected to be unchanged in the range of € 105 – 120 m (new guidance range at constant exchange rates of € 85 – 100 m versus € 95 – 110 m previously) (2021: € 107 m)
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58 m)
Mid-term goals target revenue growth to more than € 1,000 m, adjusted EBITDA of at least € 300 m and unpartnered research and development expenses of more than € 100 m
The forecast takes in account – as far as possible – the current increased global uncertainties related to e.g. the COVID-19 pandemic and the war in Ukraine, resulting in uncertainty around the global price and supply situation for energy, other raw materials and supplies as well as logistics relevant to the business.

More detailed information and financial tables are available in our half-year report published on the Evotec website under the following link: View Source

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. The conference call will be held in English.