On May 10, 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 quarter ended March 31, 2022 (Press release, Werewolf Therapeutics, MAY 10, 2022, View Source [SID1234614048]).

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"To date in 2022, we have successfully executed against corporate and strategic objectives, most notably, signing a collaboration and licensing agreement with Jazz Pharmaceuticals for the global development and commercialization of WTX-613," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. "Beyond supporting our conviction in the power of our innovative PREDATOR platform and the viability of WTX-613 as a next-generation IFNα for treatment of cancer, this agreement provides important access to non-dilutive capital, which, together with our updated term loan facility, extends our cash runway through at least the fourth quarter of 2023. Further, we remain on track as we advance towards clinical development for WTX-124 and WTX-330, while progressing our broader research portfolio in parallel."

First Quarter 2022 and Recent Business Highlights

Entered into exclusive global license and collaboration agreement with Jazz Pharmaceuticals to develop WTX-613: In April 2022, Jazz and Werewolf announced that they entered into a licensing agreement under which Jazz has acquired exclusive global development and commercialization rights to Werewolf’s investigational candidate WTX-613, an IFN⍺2b cytokine pro-drug, currently in preclinical development for a range of cancer types. 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. Pending approval, Werewolf is eligible to receive a tiered, mid-single-digit percentage royalty on net sales of WTX-613. Jazz is responsible for funding all preclinical and IND-enabling activities conducted by Werewolf for WTX-613 and is responsible for the submission of an investigational new drug application for WTX-613 and all subsequent clinical development and commercialization activities.

Presented preclinical data on two lead INDUKINE molecules at AACR (Free AACR Whitepaper): In April 2022, Werewolf presented promising preclinical data on its IL-2 and IL-12 INDUKINE molecules, WTX-124 and WTX-330, during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. WTX-124 demonstrated high tumor selectivity and generated significant anti-tumor activity in a CD8+ T cell-dependent manner, and the WTX-330 surrogate demonstrated significant expansion of the therapeutic

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window compared to recombinant IL-12 and generated potent anti-tumor immunity in multiple syngeneic tumor models.

Published preclinical data demonstrating efficacy of WTX-124 in delivering IL-2 selectively to the tumor microenvironment: In March 2022, Werewolf announced the publication of preclinical data for its lead molecule, WTX-124, in peer-reviewed Cancer Immunology Research. The article entitled, "Discovery of a conditionally activated IL-2 that promotes anti-tumor immunity and induces tumor regression," includes preclinical data that highlights WTX-124’s design in delivering IL-2 selectively to the tumor microenvironment where it stimulates a potent anti-tumor immune response.

Entered into $40.0 million term loan facility: In April 2022, Werewolf entered into an amended term loan facility with Pacific Western Bank (PWB), which provides access to up to $40.0 million across two tranches, $20.0 million of which is available at Werewolf’s discretion and $20.0 million upon the acceptance by the U.S. Food and Drug Administration of two investigational new drug application submissions on or before March 31, 2023.

First Quarter 2022 Financial Highlights
•Cash position: As of March 31, 2022, cash and cash equivalents were $143.7 million, compared to $157.5 million as of December 31, 2021. This quarter-end balance does not reflect $15.0 million upfront proceeds received in April from the collaboration agreement with Jazz. The Company expects that its existing cash and cash equivalents, together with the upfront payment from the Jazz agreement as well as access to the $20.0 million first tranche of its term loan agreement with PWB, will be sufficient to enable the funding of its operating expenses and capital expenditure requirements through at least the fourth quarter of 2023.
•Research and development expenses: Research and development expenses were $10.9 million for the first quarter of 2022, compared to $4.8 million for the same period in 2021. The increase in research and development expenses was primarily due to increased manufacturing, contract research organization, and personnel expenses incurred to advance the Company’s product candidates WTX-124, WTX-330 and WTX-613 and expand research and development activities.
•General and administrative expenses: General and administrative expenses were $4.4 million for the first quarter of 2022, compared to $2.6 million for the same period in 2021. The increase in general and administrative expenses was primarily due to increased personnel, professional services, and other operating costs attributable to operating as a public company.
•Net loss: Net loss was $15.3 million for the first quarter of 2022, compared to $7.4 million for the same period in 2021.

On May 10, 2022 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported the initiation of a Phase 1 clinical trial with its T cell engaging receptor (TCER) IMA401 for patients with recurrent and/or refractory solid tumors (Press release, Immatics, MAY 10, 2022, View Source [SID1234614047]). IMA401 is the most advanced product candidate from Immatics’ TCR Bispecific pipeline targeting an HLA-A*02-presented peptide derived from both MAGEA4 and MAGEA8. TCER IMA401 will be developed in collaboration with Bristol Myers Squibb. Immatics is responsible for conducting the Phase 1 clinical trial.

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The primary objectives of the clinical trial (NCT#05359445) are to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for IMA401 in biomarker-positive (HLA-A*02:01 and MAGEA4/8) patients with recurrent and/or refractory solid tumors. Secondary objectives are to characterize safety and tolerability, evaluate initial anti-tumor activity and assess pharmacokinetics of IMA401. The Phase 1 trial consists of a dose-escalation (Phase 1a) portion that will be followed by a dose-expansion (Phase 1b) portion to treat patients at the recommended dose level. The trial is planned to be conducted at up to 15 centers in Germany, with the first site already being initiated. The Phase 1 trial is designed to enroll approximately 50 patients.

"IMA401 is the first TCER candidate from our TCR Bispecifics pipeline entering clinical development, and expands our clinical portfolio with an exciting new TCR-based immunotherapy approach that can be supplied off-the-shelf compared to autologous cell therapies," said Cedrik Britten, Chief Medical Officer at Immatics. "Our innovative TCER format leads to an extended-half-life and incorporates novel binding-moieties that are designed to maximize efficacy while minimizing toxicities in patients. Our TCER IMA401 could treat a range of solid tumors and therefore meet currently unmet needs of a broad patient population. This is best achieved with a strong pharma partner which we have found in Bristol Myers Squibb."

Immatics entered into a global exclusive license agreement with Bristol Myers Squibb in December 2021 for the IMA401 program under which both companies will collaborate to advance the program through clinical development.

Immatics’ TCR Bispecific pipeline includes a second TCER product candidate, IMA402, which targets PRAME. Manufacturing of the clinical IMA402 batch is planned for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023. Immatics’ TCER pipeline is further strengthened by additional innovative TCER program(s), IMA40X, in preclinical development.

About IMA401
IMA401 is Immatics’ most advanced TCER molecule that targets an HLA-A*02-presented (human leukocyte antigen) peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 ("MAGEA4/8"). The MAGEA4/8 peptide has been identified and validated by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT and is presented at a 5-fold higher copy number per tumor cell than a MAGEA4 peptide targeted in other clinical trials. Following preclinical proof-of-concept data, including complete remissions of transplanted human-derived tumors in xenograft mouse models, the Phase 1 trial investigates IMA401 in patients with tumors of high MAGEA4/8 prevalence, such as squamous non-small cell lung carcinoma (sqNSCLC), small cell lung cancer (SCLC), head and neck squamous cell carcinoma (HNSCC), bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types.

About TCER
Immatics’ half-life extended TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. Immatics proprietary biologics are engineered with two binding regions: a TCR domain and a T cell recruiter domain. The TCER format is designed to maximize efficacy while minimizing toxicities in patients. It contains a high-affinity TCR domain that is designed to bind specifically to the cancer target peptide on the cell surface presented by an HLA molecule. The antibody-derived, low-affinity T cell recruiter domain is directed against the TCR/CD3 complex and recruits a patient’s T cells to the tumor to attack the cancer cells. With a low-affinity recruiter aiming for optimized biodistribution and enrichment of the molecule at the tumor site instead of the periphery, TCER are engineered to reduce the occurrence of immune-related adverse events, such as cytokine release syndrome. In addition, the TCER format consists of an Fc-part conferring half-life extension, stability, and manufacturability. TCER are "off-the-shelf" biologics and thus immediately available for patient treatment. They can be distributed through standard pharmaceutical supply chains and provide the opportunity to reach a large patient population without the need of specialized medical centers.

On May 10, 2022 Iktos, a company specialized in Artificial Intelligence (AI) for new drug design and Sygnature Discovery, a leading integrated drug discovery CRO headquartered in Nottingham, UK, with expertise across a range of therapeutic and biological target classes reported a collaboration agreement in AI for new drug design (Press release, Iktos, MAY 10, 2022, View Source [SID1234614046]).

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Under the 3-year agreement, Sygnature will deploy Iktos’ de novo generative design software Makya, which will be used by Sygnature scientists to facilitate rapid and efficient design of novel compounds and accelerate hit-to-lead/lead optimisation, reinforcing Sygnature Discovery’s drug design expertise delivering its integrated drug discovery solutions to its world-wide customer base.

In the recent years, Iktos has emerged as one of the world leaders in AI for drug design, establishing multiple collaborations with renowned pharmaceutical companies and successfully developing the AI software platforms Makya for new drug design and Spaya for synthesis planning.

Makya, a generative AI-driven de novo design software for Multi-Parametric Optimization (MPO), is available either as a SaaS platform or for implementation on customer premises or in the customer’s Virtual Private Cloud (VPC). Makya’s user-friendly interface enables it to be used by medicinal or computational chemists, and Makya can also be operated as a Python package through a Jupyter notebook interface. Makya is based on Iktos’ generative AI technology, which helps bring speed and efficiency to the drug discovery process by automatically designing virtual novel molecules that have desired activities for treating a given disease. It is a novel solution, validated through many collaborations, to one of the key challenges in drug design: the rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties.

Sygnature Discovery serves its growing customer base with fully integrated drug discovery services from target validation through to preclinical candidate selection. The company has a relentless focus on quality and continually looks to improve on its ability to deliver novel therapeutics to the clinic.

Colin Sambrook-Smith, Director of Computational Sciences at Sygnature Discovery commented:

"Late stage lead optimisation projects routinely generate substantial data sets which are ideally placed for exploitation by AI and Machine Learning technologies. Our experience with the Iktos Makya AI/ML technology demonstrates that it generates high quality compound ideas, the QSAR models can be rapidly updated, and the interface allows us to distribute the software broadly and quickly. We believe that Makya will allow us to blend our proven medicinal and computational chemistry expertise with the benefit of AI/ML technologies to impact compound design. This is why we have selected Makya to enhance how we help our customers with their lead optimisation projects, with a view to reducing the number of compounds required to identify pre-clinical candidates and so keep overall costs and timelines down."

"We are very pleased to collaborate with Sygnature Discovery, they truly are a leading integrated drug discovery CRO and with a great track record. We are excited and proud to announce our first multi-year collaboration deal in the dynamic CRO sector and to have Sygnature’s scientists use our software to speed up their customers’ discovery programs," said Yann Gaston-Mathé, Co-founder and CEO of Iktos. "We are more than ever committed to make our technology available to biopharma companies around the world and maximize the impact of AI on the productivity of drug discovery."

On May 10, 2022 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that its management team will participate in the following upcoming investor conferences and events (Press release, Calliditas Therapeutics, MAY 10, 2022, View Source [SID1234614045]):

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The 8th Annual LSX World Congress on May 10-11, 2022 in London, United Kingdom
The ABGSC Life Science Summit on May 18–19, 2022, in Stockholm, Sweden.
H.C. Wainwright Hybrid Global Investment Conference on May 23-26, 2022.
Jefferies Healthcare Conference on June 8-10, 2022 in New York City, USA.
Citi European Healthcare Conference on June 14–16, 2022 in London, United Kingdom
At the LSX World Congress, Calliditas Chief Executive Officer Renée Aguiar-Lucander, Chief Financial Officer Fredrik Johansson and President of North America, Andrew Udell will speak in three separate panel discussions focused on global commercial strategy, IPO listings, and product launching, respectively.

Renee Aguiar-Lucander will present at the ABGSC Life Science Summit on May 19th at 11:30am to 12pm CET.

Management will be presenting and will host one-on-one investor meetings at the other three conferences. To schedule a one-on-one meeting with Calliditas, please contact your representative at H.C Wainwright, Jefferies, or Citi.

The information was sent for publication, through the agency of the contact persons set out above, on May 10, 2022 at 8:30 a.m. CET.

On May 10, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate in a fireside chat at the 2022 RBC Capital Markets Global Healthcare Conference on Tuesday, May 17, 2022 at 4:35 p.m. ET in New York, NY (Press release, Karyopharm, MAY 10, 2022, View Source [SID1234614025]).

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A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay for 90 days following the event.