On August 11, 2022 AstraZeneca reported that it has completed the acquisition of TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma (Press release, Verrica Pharmaceuticals, AUG 11, 2022, View Source [SID1234618152]).1 AstraZeneca will develop TNB-486 as a potential new medicine for B-cell haematologic malignancies.

Financial considerations
AstraZeneca has acquired all outstanding equity of TeneoTwo in exchange for an upfront payment of $100m. Under the terms of the agreement, AstraZeneca will make additional contingent R&D-related milestone payments of up to $805m and additional contingent commercial-related milestone payments of up to $360m to TeneoTwo’s former equity holders.

This acquisition did not include the transfer of people or facilities.

iTeneoTwo, Inc., is a majority owned subsidiary company of TBio, LLC, a limited liability company formed in Delaware, US

Notes

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. We have expanded our commitment to patients with haematologic conditions, not only in oncology but also in rare diseases with the acquisition of Alexion, allowing us to reach more patients with high unmet needs. By applying our deep understanding of blood cancers, leveraging our strength in solid tumour oncology and delivering on Alexion’s pioneering legacy in complement science to provide transformative medicines for rare diseases, we are pursuing the end-to-end development of novel therapies designed to target underlying drivers of disease.

By targeting haematological conditions with high unmet medical needs, we aim to deliver innovative medicines and approaches to improve patient outcomes. Our goal is to help transform the lives of patients living with malignant, rare and other related haematologic diseases, shaped by insights from patients, caregivers and physicians to have the most meaningful impact.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

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On August 11, 2022 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the second quarter, ended June 30, 2022 (Press release, Monte Rosa Therapeutics, AUG 11, 2022, View Source [SID1234618150]).

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"Over the last few months, we have made important progress in advancing our pipeline of molecular glue degraders, culminating most recently in the submission of our investigational new drug (IND) application for MRT-2359," said Markus Warmuth, M.D., CEO of Monte Rosa. "With a strong balance sheet and cash runway into late 2024, we are well positioned for our planned clinical trial in patients with Myc-driven tumors, including both small cell and non-small cell lung cancer. This brings us one step closer to delivering on the promise of our QuEEN platform to deliver MGDs that eliminate with high selectivity disease-relevant protein targets previously considered undruggable."

SECOND QUARTER 2022 & RECENT HIGHLIGHTS

Submitted IND application to the U.S. Food and Drug Administration (FDA) in August for MRT-2359, a potent and selective GSPT1-directed molecular glue degrader
Continued progress of CDK2 and NEK7 programs toward development candidate nominations
UPCOMING MILESTONES & PRESENTATIONS

Initiation of a Phase 1/2 trial for MRT-2359 for the treatment of Myc-driven tumors, including lung cancer, in the fourth quarter of 2022, subject to FDA clearance of IND
Initiation of at least one additional lead optimization program in 2022
Upcoming scientific conferences and presentations:
Multiple members of the Monte Rosa team to present at the 5th Annual Targeted Protein Degradation Summit, Oct. 25-28 in Boston. Silvia Buonamici, Ph.D., SVP, Drug Discovery Biology, will present an overview of MRT-2359 preclinical studies to support development in Myc-driven lung cancer on Oct. 27
Filip Janku, M.D., Ph.D., Chief Medical Officer, to present an overview of the development of MRT-2359 as a GSPT1-directed molecular glue degrader to target Myc-driven malignancies at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Oct. 28
UPCOMING INVESTOR EVENTS

Monte Rosa will be participating in the following upcoming investor conferences:

Citi’s 17th Annual BioPharma Conference, Sept. 7-8, Boston
2022 Wells Fargo Healthcare Conference, Sept. 7-9, Boston
Morgan Stanley 20th Annual Global Healthcare Conference, Sept. 12-14, New York
Guggenheim Therapeutics Conference, Sept. 27-29, Nantucket
SECOND QUARTER 2022 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2022 were $20.9 million, compared to $14.6 million for the second quarter of 2021. These increases were due to the expansion of R&D activities, including the advancement of MRT-2359 toward clinical development and the development of the company’s QuEEN platform and its preclinical programs, as well as increased headcount and laboratory-related expenses due to the company’s continued growth as an R&D organization. R&D expenses for the second quarter of 2022 included non-cash stock-based compensation of $1.4 million and non-cash lease expense of $1.3 million due to a rent holiday on the company’s Harrison Street facility lease. The same period in 2021 included non-cash stock-based compensation expense of $0.4 million.

General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2022 were $6.3 million compared to $3.5 million for the second quarter of 2021. The increase in G&A expenses was a result of additional expenses incurred in support of the company’s growth and operations as a public company. G&A expenses included non-cash stock-based compensation of $1.4 million for the second quarter of 2022, compared to $0.6 million for the same period in 2021.

Net Loss: Net loss for the second quarter of 2022 was $26.5 million, compared to $18.4 million for the second quarter of 2021.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash and marketable securities as of June 30, 2022, were $299.5 million, compared to cash, cash equivalents and restricted cash of $322.5 million as of March 31, 2022. The decrease primarily related to cash used to fund operations of $20.5 million and cash used to purchase laboratory equipment of $1.3 million, partially off-set by proceeds from the exercise of stock options of $0.1 million. The company expects that its cash and cash equivalents will be sufficient to fund planned operations and capital expenditures into late 2024.

On August 11, 2022 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, reported financial results for the second quarter of 2022 (Press release, Abeona Therapeutics, AUG 11, 2022, View Source [SID1234618149]). The Company will host a conference call and webcast today, August 11, 2022, at 8:30 a.m. ET, to discuss its financial results and business update.

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"We have taken decisive action to focus our resources on our lead asset EB-101, for which we expect pivotal Phase 3 VIITAL topline results in the coming months," said Vish Seshadri, Chief Executive Officer of Abeona. "With Ultragenyx assuming all financial responsibility for the continued development of ABO-102, we were able to extend our cash runway well beyond the VIITAL data readout. The additional runway puts us in a strong position to forge the optimal commercial partnership that fully appreciates the value of EB-101 post-data readout."

Second Quarter and Recent Operating Highlights

Ultragenyx Pharmaceutical Inc. and Abeona entered into an exclusive license agreement for ABO-102 (now UX111) for Sanfilippo syndrome type A (MPS IIIA), under which Ultragenyx assumes responsibility for the ABO-102 program and in return Abeona is eligible to receive tiered royalties and commercial milestone payments following potential regulatory approval.
Topline data from the Phase 3 VIITAL study of EB-101 in RDEB is on track for late third quarter to early fourth quarter of 2022 upon completion of the last patient monitoring visit, which is expected by mid-September. Baseline wound characteristics underscore the large size and severe pain associated with wounds included in VIITAL. Treated randomized wounds had mean per patient body surface area of 156 cm2, the largest reported for pivotal studies in RDEB. Baseline pain reported for randomized wounds using the Wong-Baker FACES Pain Rating Scale of 0-10 further highlights the severity of these wounds, with eight of the 11 patients reporting a minimum pain score of 6 in at least one randomized wound and four of the 11 patients reporting a maximum baseline pain score of 10 for certain randomized wounds.
Additional long-term follow up data up to eight years and quality of life data from a completed Phase 1/2 study evaluating EB-101 for RDEB were presented at the Society of Investigative Dermatology (SID) Annual Meeting. The data showed EB-101 treatment of large chronic RDEB wounds resulted in considerable wound healing with mean 5.9 years of follow-up. In addition, reduced wound burden was associated with long-term symptomatic relief, including reduction in pain.
Reported non-human primate data for AAV204, a novel adeno-associated virus (AAV) capsid from Abeona’s AIM capsid library, highlighting its ability to produce more robust transduction in the macula area of the eye following para-retinal administration, which unlike subretinal administration does not create a retinal detachment. The data was featured at the Association for Research and Vision in Ophthalmology (ARVO) 2022 Annual Meeting.
On July 19, 2022, Abeona received notice from Nasdaq that the Company has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market.
Second Quarter Financial Results

Cash, cash equivalents, restricted cash and short-term investments totaled $26.0 million as of June 30, 2022. Net cash used in operating activities was $9.0 million for the second quarter of 2022, compared to $13.7 million in the first quarter of 2022.

License and other revenues in the second quarter of 2022 were $1.0 million, compared to nil in the second quarter of 2021. The revenue in the second quarter of 2022 resulted from a clinical milestone achieved under a sublicense agreement with Taysha Gene Therapies relating to an investigational AAV-based gene therapy for Rett syndrome, including certain intellectual property relating to MECP2 gene constructs and regulation of their expression.

Research and development (R&D) expenses for the three months ended June 30, 2022 were $6.7 million, compared to $8.5 million for the same period of 2021. General and administrative (G&A) expenses were $3.5 million for the three months ended June 30, 2022, compared to $5.2 million for the same period of 2021.

Net loss attributable to common shareholders for the second quarter of 2022 was $12.1 million, or $2.08 loss per common share as compared to $15.2 million, or $3.93 loss per common share, in the second quarter of 2021.

Conference Call Details

Abeona Therapeutics will host a conference call and webcast today, August 11, 2022, at 8:30 a.m. ET, to discuss its financial results and business update. To access the call, dial 877-545-0523 (U.S. toll-free) or 973-528-0016 (international) and Entry Code: 857476 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com. The archived webcast replay will be available for 30 days following the call.

On August 11, 2022 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development, and commercialization of transformative targeted therapies, reported business and pipeline highlights and reported financial results for the second quarter ended June 30, 2022 (Press release, Theseus Pharmaceuticals, AUG 11, 2022, View Source [SID1234618148]).

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"At Theseus, we are developing next-generation tyrosine kinase inhibitors (TKIs) to outsmart cancer resistance—a key challenge facing existing therapies in targeted oncology. 2022 is a critical year of execution and we have continued to make significant progress across our programs," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "Enrollment in the dose escalation portion of the Phase 1/2 trial of THE-630 in patients with advanced GIST is on track and we look forward to the expected announcement of initial clinical data in the first half of 2023. We are on track to nominate a development candidate for our EGFR inhibitor program for the treatment of non-small cell lung cancer in the third quarter of 2022 and plan to present preclinical data supporting the promising profile for this candidate in the fourth quarter of 2022. We expect to expand our pipeline with the introduction of a third TKI program later this year."

Recent Pipeline Highlights and Upcoming Expected Milestones:

THE-630: a single molecule, pan-variant inhibitor of the receptor tyrosine kinase KIT. Designed for patients whose gastrointestinal stromal tumors (GIST), a disease that remains largely KIT-dependent following multiple lines of treatment, has developed resistance to earlier lines of therapy.

A Phase 1/2 dose-escalation and expansion clinical trial evaluating THE-630 in patients with advanced GIST is ongoing, as the Company completes site activations and continues to enroll patients in the dose-escalation portion of the trial.
Initial data from the Phase 1 dose-escalation portion of the clinical trial are expected to be presented at a scientific conference in the second quarter of 2023.
EGFR inhibitor for non-small cell lung cancer (NSCLC): a fourth-generation, single molecule, selective EGFR inhibitor, designed to inhibit all major single-, double-, and triple-mutant EGFR variants found in the tumors of patients with EGFR-mutant NSCLC that have developed resistance to first- or later-line osimertinib treatment, including the C797S and T790M mutations, with central nervous system (CNS) activity.

Theseus expects to nominate a development candidate for this program in the third quarter of 2022 and to introduce this candidate along with a presentation of new preclinical data at a scientific conference in the fourth quarter of 2022.
Theseus expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in 2023.
At the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022, the Company presented preclinical data demonstrating that pan-variant inhibition of all major EGFR mutations consisting of single-, double-, and triple-EGFR mutants, including T790M and C797S, with selectivity over wild-type and CNS activity, can be achieved with a single molecule.
R&D Portfolio: Theseus’ discovery platform incorporates its structure-guided drug design and predictive resistance assay (PRA) to develop next-generation, pan-variant inhibitor molecules targeting all major cancer-causing and treatment-resistance mutations of tyrosine kinase targets.

The Company continues advancing its preclinical discovery pipeline and expects to introduce a new kinase target program by the end of 2022.
Business Highlights:

In May 2022, Theseus announced the appointment of Don Hayden to its Board of Directors. Mr. Hayden brings over 40 years of industry experience to the Board, including previously serving as President of Oncology and Immunology and as President of Global Pharmaceuticals at Bristol Myers-Squibb and as Chair at numerous biotech companies.
In June 2022, Theseus appointed Steve Tuller as Vice President, Quality Assurance. Mr. Tuller has 24 years of experience in the pharmaceutical and biotechnology industries. Before joining Theseus, he served as Vice President, Head of Quality Assurance at Epizyme, Inc., where he initiated the GxP Quality Assurance organization.
Second Quarter Financial Results:

Cash Position: As of June 30, 2022, Theseus had cash, cash equivalents and short-term and long-term investments of $228.6 million. Theseus expects its cash, cash equivalents, and investments to fund operations and capital expenditures into the fourth quarter of 2024 based on its current operating plan.

R&D Expenses: Research and development expenses were $7.3 million for the second quarter of 2022, as compared to $4.5 million for the same period in 2021. This increase was primarily due to $2.0 million of increased employee-related costs, and $0.6 million of increased expenses for clinical and preclinical studies.

G&A Expenses: General and administrative expenses were $4.7 million for the second quarter of 2022, as compared to $2.3 million for the same period in 2021. This increase was primarily due to $1.6 million of increased employee-related costs, as well as $0.5 million of increased professional fees.

Net Loss: Net loss was $11.6 million for the second quarter of 2022, as compared to a net loss of $6.8 million for the same period in 2021.

On August 11, 2022 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, reported financial results for the second quarter ended June 30, 2022 (Press release, Werewolf Therapeutics, AUG 11, 2022, View Source [SID1234618147]).

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"Werewolf continues to advance our conditionally activated INDUKINE therapies into clinical development," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "Most notably, we received FDA clearance to launch our first-in-human study of WTX-124, an IL-2 INDUKINE, for treatment of advanced solid tumors, marking our transition to a clinical-stage company. Additionally, we are planning to submit an IND for our IL-12 INDUKINE, WTX-330, in the second half of 2022. We believe that these initial candidates offer compelling opportunities not just to advance patient outcomes in their respective indications, but also to validate the distinct advantages of our platform. Importantly, we believe that we remain well-capitalized to advance clinical development for both programs as we proceed with novel discovery efforts in parallel."

Recent Highlights and Upcoming Milestones

WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule in development as monotherapy or in combination with checkpoint inhibitors in multiple solid tumor types.

During the second quarter of 2022, Werewolf received clearance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for WTX-124. This Phase 1/1b clinical trial will evaluate WTX-124 as a monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced or metastatic solid tumors.
The Company plans to provide an update after dosing the first patient in the WTX-124 Phase 1/1b clinical trial.
WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule in development as monotherapy or in combination with checkpoint inhibitors in refractory and/or immunologically unresponsive tumors.

Werewolf is concluding IND-enabling work for WTX-330 and is planning to submit an IND application for this program in the second half of 2022.
Corporate:

In April 2022, Jazz Pharmaceuticals (Jazz) and Werewolf entered into a collaboration and license agreement under which Werewolf granted Jazz certain licenses to develop and commercialize WTX-613 (now known as JZP898), an Interferon alpha (IFNα) molecule. During the second quarter of 2022, Werewolf received an upfront payment of $15.0 million from Jazz and is eligible to receive up to $520.0 million in development and regulatory milestones and up to $740.0 million in commercial milestone payments, as well as a tiered, mid-single-digit percentage royalty on net sales, pending approval.
Second Quarter 2022 Financial Highlights

Cash position: As of June 30, 2022, cash and cash equivalents were $145.7 million, compared to $157.5 million as of December 31, 2021. The Company expects that its existing cash and cash equivalents will be sufficient to enable funding of its operating expenses and capital expenditure requirements through at least the fourth quarter of 2023.
Collaboration revenue: Collaboration revenue was $4.1 million for the second quarter of 2022, compared to zero for the same period in 2021. Collaboration revenue is related to amortization of the $15.0 million upfront payment received in April 2022 upon the execution of Werewolf’s licensing agreement with Jazz and costs incurred for research services to be reimbursed by Jazz.
Research and development expenses: Research and development expenses were $13.9 million for the second quarter of 2022, compared to $7.3 million for the same period in 2021. The increase in research and development expenses was primarily due to manufacturing expenses incurred to support the production of preclinical and future clinical trial materials associated with the Company’s product candidates WTX-124, WTX-330 and WTX-613, increased employee compensation costs related to increased headcount and increased contract research organization expenses incurred to support IND-enabling studies and clinical start-up activities for WTX-124 and WTX-330.
General and administrative expenses: General and administrative expenses were $5.2 million for the second quarter of 2022, compared to $3.7 million for the same period in 2021. The increase in general and administrative expenses was primarily due to increased personnel and other costs attributable to operating as a public company.
Net loss: Net loss was $14.6 million for the second quarter of 2022, compared to $10.9 million for the same period in 2021.