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Invitation to Scandion Oncology A/S webcast and conference call 19 August 2021

On August 12, 2021 Scandion Oncology A/S reported that it will publish its Half-year report on Thursday, 19 August 2021 before 09:00 CET (Press release, Scandion Oncology, AUG 12, 2021, View Source,c3395664 [SID1234586412]).

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Scandion Oncology’s executive management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

The information was provided by the contact person above for publication on 12 August 2021.

Zentalis Pharmaceuticals Reports Second Quarter 2021 Financial Results and Operational Update

On August 12, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the second quarter ended June 30, 2021 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, AUG 12, 2021, View Source [SID1234586381]).

"We have had an extremely productive second quarter, marked by significant clinical and regulatory advances that were outlined in our mid-year review in June. The data presented continue to support our candidates’ potential for best-in-class positioning – both as monotherapies and in combinations – for an array of difficult-to-treat cancers," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Of note, our lead candidate, ZN-c3, demonstrated additional deepening and durable tumor responses, and based on this maturing data presented in June, we have identified potential accelerated approval paths for this candidate in USC and a biomarker-driven setting, with the Phase 2 trial in USC already underway."

Continued Dr. Sun, "Furthermore, this momentous period for Zentalis was reinforced by the completion of a recent upsized public offering in which we raised approximately $173 million in gross proceeds. This financing ensures we are well-positioned to fund all upcoming key milestones, with the goal of delivering differentiated cancer treatments to patients globally."

Program Highlights:

In June 2021, Zentalis hosted a mid-year update webcast, providing key clinical and regulatory updates across its pipeline. Clinical highlights from the update included: five confirmed Partial Responses (PRs) and one unconfirmed PR in the Phase 1 monotherapy trial of ZN-c3 in a range of heavily pre-treated solid tumors; plans for two potentially registrational trials for ZN-c3 in USC and a biomarker-driven setting; an oral dose of 50 mg QD demonstrating a Clinical Benefit Rate of 40% in the Phase 1 monotherapy trial of ZN-c5 in ER+/HER2- breast cancer. For more information on the clinical results reported, click here.

In July 2021, the Company dosed the first patient in a Phase 2 trial of ZN-c3 in women with recurrent or persistent USC. Following an end-of-Phase 1 meeting, the U.S. Food and Drug Administration (FDA) agreed in principle that ZN-c3 has the potential for an accelerated approval pathway based on the Phase 2 global study design in USC.

In June 2021, the Company received orphan drug and rare pediatric disease designations from the FDA for ZN-c3 in combination with chemotherapy for the treatment of osteosarcoma. Zentalis expects to initiate a Phase 1/2 trial in 3Q 2021.

In April 2021, Zentalis reported initial results from the Phase 1 portion of a Phase 1/2 trial of ZN-c3 in advanced solid tumors in a late-breaking session at the AACR (Free AACR Whitepaper) Annual Meeting, which was further discussed at a webcast event with Key Opinion Leaders.

In April 2021, Zentalis entered into a Clinical Trial Collaboration and Supply Agreement with GSK to investigate the combination of ZN-c3 and niraparib, GSK’s poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with advanced epithelial ovarian cancer. The Company expects to initiate a Phase 1b trial with this combination in the second half of 2021.
Zentera Highlights:

In July 2021, Zentera, a Shanghai-based clinical-stage biopharmaceutical company formed by Zentalis, announced the completion of a $75 million Series B financing. The proceeds will be used to advance the clinical development of three Zentalis-discovered candidates, ZN-c3, ZN-c5 and ZN-d5, in China, in addition to business development opportunities for pipeline expansion.

As of July 2021, Zentera had received CTA acceptances in China for ZN-c3, ZN-c3 in combination, ZN-c5 and ZN-d5. Two clinical trials are ongoing with plans to initiate one more trial by year-end 2021.
Corporate Highlights:

In July 2021, Zentalis closed an underwritten public offering of 3,565,000 shares of its common stock at a public offering price of $48.50 per share. The total gross proceeds were approximately $172.9 million, before deducting underwriting discounts and commissions and offering expenses payable by Zentalis.
Second Quarter 2021 Financial Results

Cash and Marketable Securities Position: As of June 30, 2021, Zentalis had cash, cash equivalents and marketable securities of $250.9 million. We believe that our existing cash, cash equivalents and marketable securities as of June 30, 2021, together with the net proceeds from our July 2021 follow-on offering, will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2023.

Research and Development Expenses: Research and development expenses for the three months ended June 30, 2021 were $44.8 million, compared to $17.5 million for the three months ended June 30, 2020. The increase of $27.3 million was primarily due to increases in external research and development expenses related to our lead product candidates, as we advanced our Phase 1/2 clinical trials for ZN-c3 and ZN-c5. In addition, in the three months ended June 30, 2021, we conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials.

General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2021 were $10.4 million, compared to $9.9 million during the three months ended June 30, 2020. This increase of $0.5 million was primarily attributable to an increase of $2.0 million in employee-related and supply costs, partially offset by a reduction in allocable overhead facility expenses.

Net Loss: Net loss was $55.1 million for three months ended June 30, 2021, compared to $27.3 million for the three months ended June 30, 2020. The $27.8 million increase in net loss was primarily the result of the increases in research and development and general and administrative expenses discussed above.

Impact from COVID-19 Pandemic: Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty and cannot be predicted with confidence, we continue to use the best information available to inform our critical accounting estimates.

HOOKIPA Pharma Reports Second Quarter 2021 Financial Results and Recent Highlights

On August 12, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the second quarter of 2021 (Press release, Hookipa Biotech, AUG 12, 2021, View Source [SID1234586380]).

"During the second quarter, we gained considerable momentum in highlighting the promise of our novel arenaviral platform to redefine success in cancer immunotherapy. Our HB-200 program in advanced Human Papillomavirus 16-positive (‘HPV16+’) cancers was featured prominently at both AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper), with compelling tumor antigen-specific T cell responses and tumor control that replicate pre-clinical results," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We are focused on advancing our oncology and infectious disease programs through the second half of the year, as we aim to deliver first-in-class arenaviral immunotherapies that induce potent, targeted immune responses to fight or prevent serious disease."

Quarter Highlights

At the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) (‘AACR’) Annual Meeting in April 2021, HOOKIPA presented positive preliminary Phase 1 immunogenicity data for HB-200 for the treatment of advanced HPV16+ cancers. These data demonstrated a robust increase in HPV16+-specific T cells, including an increase of up to 8% of antigen-specific circulating CD8+ T cells, after one dose of HB-201 or HB-202. Early HB-201 monotherapy data also highlighted immune system activation of increasing interferon-gamma and other immune stimulatory cytokines with a single dose.

In June, HOOKIPA reported positive Phase 1 data from the ongoing Phase 1/2 study of HB-200 for the treatment of advanced HPV16+ cancers. The clinical data, presented as an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (‘ASCO’) Annual Meeting, showed HB-200 is highly immunogenic, inducing unprecedented levels of activated, tumor antigen-specific CD8+ T cells (an average of 6 percent and up to 40 percent of the T cell pool). In addition, HB-201 monotherapy showed an 18 percent overall response rate and median progression-free survival of 3.45 months in heavily pre-treated head and neck cancer patients who progressed on standard of care, including checkpoint inhibitors.

HOOKIPA completed enrollment in the Phase 2 clinical trial of its prophylactic Cytomegalovirus (‘CMV’), vaccine candidate, HB-101; the last patient was enrolled in June 2021. We expect to report additional safety, immunogenicity, and efficacy data from evaluable patients in the second half of 2021, with final top-line data readout in the first half of 2023. The protocol requires a 12-month follow up after transplantation, which is typically two to three months after enrollment.

Jean-Charles Soria resigned as a Non-Executive Director of HOOKIPA’s Board of Directors to avoid any conflicts of interest following a decision to join Amgen as senior vice president and lead of the oncology therapeutic area.
Upcoming Milestones

Additional HB-201/HB-202 Phase 1/2 data in HPV16+ cancers and recommended Phase 2 dose for the HB-200 program in the fourth quarter of 2021
HB-101 CMV Phase 2 data in the second half of 2021
Advancing our HB-300 program to IND for the treatment of metastatic prostate cancer
HBV and HIV collaboration with Gilead Sciences advancing towards clinical studies
Second Quarter 2021 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of June 30, 2021 was $102.9 million compared to $143.2 million as of December 31, 2020. The decrease was primarily attributable to cash used in operating activities.

Revenue was $5.4 million for the three months ended June 30, 2021, and $6.7 million for the three months ended June 30, 2020. The decrease was primarily due to receipt of a $1.0 million milestone payment under the Gilead collaboration during this time period in 2020, but not in 2021.

Research and Development Expenses: HOOKIPA’s research and development expenses were $19.6 million for the three months ended June 30, 2021, compared to $11.6 million for the three months ended June 30, 2020.

The primary drivers of the increase in direct research expenses were an increase in manufacturing and quality control expenses of $1.6 million, and an increase in clinical operations expenses of $1.4 million, along with a general increase in other direct research and development expenses and laboratory expenses of $2.4 million. These expenses were mainly due to the progress in our HB-201 and HB-202 clinical trial, in particular for monitoring and testing activities, and manufacturing and quality control work in preparation of a further extension of the trial. Manufacturing and quality control expenses were also driven by the progress towards clinical development in our Gilead-partnered programs.

Internal research and development expenses increased by $2.6 million, mainly due to our increased research and development headcount.

General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2021 were $5.1 million, compared to $4.3 million for the three months ended June 30, 2020. The increase was primarily due to an increase in personnel-related expenses, partially offset by a decrease in professional and consulting fees. The increase in personnel-related expenses resulted from a growth in headcount along with increased salaries in our general and administrative functions, and increased stock compensation expenses.

Net Loss: HOOKIPA’s net loss was $17.2 million for the three months ended June 30, 2021, compared to a net loss of $7.1 million for the three months ended June 30, 2020. This increase was due to an increase in research and development expenses, an increase in general and administrative expenses, a decrease in revenues from collaboration and licensing and a decrease in other income, partially offset by an increase in grant income.

Instil Bio Reports Second Quarter 2021 Financial Results and Provides Corporate Update

On August 12, 2021 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its second quarter 2021 financial results and provided a corporate update (Press release, Instil Bio, AUG 12, 2021, View Source [SID1234586379]).

"We confirm our commitment to initiating a Phase 2 trial of ITIL-168 in advanced melanoma in the second half of 2021," said Bronson Crouch, Chief Executive Officer of Instil. "With the installation and ongoing qualification of modular clean room pods at our Tarzana, California facility and our progress toward activating additional manufacturing capabilities in Manchester, U.K., we expect increased clinical manufacturing capacity in late 2021 and early 2022 to support our clinical development plans for ITIL-168 and ITIL-306. Our commitment to innovation in manufacturing continues with the development of a shortened 21-day manufacturing process with robust levels of TIL transduction efficiency for ITIL-306, our first genetically engineered CoStAR-TIL. We expect to pursue further enhancements to both ITIL-168 and ITIL-306 manufacturing processes in the future."

Second Quarter 2021 Highlights and Anticipated Milestones:

Clinical Development:

Presented Clinical Data in Advanced Melanoma at AACR (Free AACR Whitepaper): Instil presented clinical data demonstrating a 67% objective response rate and 19% complete response rate from a compassionate use program of TILs for the treatment of metastatic melanoma as a late-breaking e-Poster at the AACR (Free AACR Whitepaper) virtual meeting in April 2021.

Orphan Drug Designation: On April 27, 2021, ITIL-168 received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV.

Phase 2 Clinical Trial Initiation of ITIL-168: Instil expects to start a Phase 2 clinical trial of ITIL-168 for the treatment of advanced melanoma in the second half of 2021. Topline safety and efficacy data would be expected in 2023, followed by submission of a BLA to the FDA and a Marketing Authorization Application to the European Medicines Agency expected in 2023 and 2024, respectively.

Phase 1 Clinical Trial Initiation of ITIL-306: Instil expects to start a Phase 1 clinical trial of ITIL-306 for the treatment of FOLR1-expressing cancer in the first half of 2022.
Manufacturing and Technical Operations:

Facility Readiness for Clinical Trials: Current manufacturing capacity in the U.K. is sufficient to support capacity needs at the start of the expected upcoming Phase 2 clinical trial of ITIL-168. Further expansion of our U.K. manufacturing capacity is expected later this year. Instil has also installed and begun qualification of its modular clean room pods at its Tarzana, California facility. These pods will support U.S. regional manufacturing and are expected to begin producing clinical batches in the first half of 2022.

ITIL-306 Manufacturing Process: Instil’s focus on continued improvements in manufacturing is highlighted by the development of a 21-day manufacturing process for ITIL-306. This process is capable of achieving high TIL transduction efficiencies that are well in excess of published literature.
Second Quarter 2021 Financial and Operating Results:

As of June 30, 2021, cash and cash equivalents totaled $566.7 million, compared to $241.7 million as of December 31, 2020. The Company expects that its cash and cash equivalents as of June 30, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses were $21.2 million and $35.6 million for the three and six months ended June 30, 2021, compared to $2.2 million and $4.2 million for the three and six months ended June 30, 2020.

General and administrative expenses were $14.2 million and $23.2 million for the three and six months ended June 30, 2021, compared to $2.4 million and $4.3 million for the three and six months ended June 30, 2020.

Anavex Life Sciences Provides Business Update and Reports Fiscal 2021 Third Quarter Financial Results

On August 12, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, reported financial results for its fiscal quarter ended June 30, 2021 (Press release, Anavex Life Sciences, AUG 12, 2021, View Source [SID1234586378]).

"We are pleased with the rigorous and efficient execution of the confirmatory late-stage Precision Medicine ANAVEX2-73 Phase 2b/3 randomized, double-blind, placebo-controlled clinical trial with a total of 509 patients with Alzheimer’s disease and are excited to be able to provide top-line data by 2H 2022. The steadfast clinical trial execution capabilities of the Anavex team also extend to the Precision Medicine ANAVEX2-73 Phase 2/3 AVATAR clinical trial in patients with Rett syndrome, which exceeded the enrollment target, and currently topline results from this study are expected by 2H 2021," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We are excited about the potential of our SIGMAR1 platform, and we continue working to advance new programs to the clinic, all with the aim of meeting the unmet clinical needs of patients with both degenerative and developmental neurological disorders around the world."

Recent Business Highlights:

On May 25, 2021, Anavex announced the appointment of Ms. Jiong Ma, PhD to its Board of Directors. Ms. Ma is a Senior Board executive with over 25 years of experience in investing, building, and scaling of companies with a focus on innovative product launches in digital health, technology, and new energy transition.
On June 8, 2021, Anavex announced that it exceeded its enrollment target for the confirmatory late-stage ANAVEX2-73 Phase 2b/3 randomized, double-blind, placebo-controlled trial in Alzheimer’s disease. The Company expects to announce topline results from this study by 2H 2022.
On June 21, 2021, Anavex reported complete data from its ANAVEX2-73 U.S. Rett syndrome Phase 2 study. Predictive biomarker of response established with SIGMAR1 mRNA expression correlates significantly with responses in primary clinical efficacy endpoints from the U.S. Phase 2 randomized, double-blind, placebo-controlled trial of ANAVEX2-73 in patients with Rett syndrome.
On June 24, 2021, Anavex announced the closing of $50 million registered direct offering to Deep Track Capital, an investment firm focused exclusively on the life sciences industry.
On June 28, 2021, Anavex reported complete data from its ANAVEX2-73 Parkinson’s disease dementia (PDD) Phase 2 study. Predictive biomarker of response established with SIGMAR1 mRNA expression correlates significantly with responses in primary and secondary clinical efficacy endpoints from the proof-of-concept randomized, double-blind, placebo-controlled Phase 2 trial of 132 patients with Parkinson’s disease dementia.
Further clinical milestones are provided in Anavex Life Sciences’ latest corporate presentation, available on anavex.com.
Financial Highlights:

Cash and cash equivalents of $157.6 million on June 30, 2021, an increase of over $128 million compared to $29.2 million from September 30, 2020.
Net loss of $10.2 million, or $0.14 per share for the quarter, compared to net loss of $6.5 million, or $0.11 per share in comparative quarter of fiscal 2020.
Research and development expenses of $9.0 million for the quarter, compared to $6.7 million for comparable quarter of fiscal 2020.
General and administrative expenses of $2.4 million for the quarter, compared to $1.4 million for comparable quarter of fiscal 2020.
The financial information for the fiscal quarter ended June 30, 2021, should be read in conjunction with the Company’s interim condensed consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

Webcast / Conference Call Information:

The live webcast of the conference call can be accessed online at View Source

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 50210582, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.