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 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported financial results for the first quarter ended March 31, 2022 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, MAY 10, 2022, View Source [SID1234614080]).

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"We started 2022 strongly, achieving record royalty revenues with significant growth that was in-line with our guidance for 2022, and with the signing of a new ENHANZE collaboration and licensing agreement with Chugai Pharmaceutical," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We were delighted to recently announce our plans to acquire Antares Pharma, Inc., which is expected to increase our top and bottom-line growth for the long term. We look forward to a transformative year as we add three commercial products and explore our combined platform capabilities and build on the strong momentum of our ENHANZE royalty business.

Recent Partner Highlights:

In March 2022, argenx announced positive topline results from its ADAPT-SC study evaluating subcutaneous (SC) efgartigimod (1000mg efgartigimod-PH20) using ENHANZE drug delivery technology for the treatment of generalized myasthenia gravis. The study met its primary endpoint, demonstrating noninferior total IgG reduction at day 29 with subcutaneously administered efgartigimod compared to intravenous (IV) administration. Based on these results, argenx has stated it plans to submit a Biologics License Application to the U.S. Food and Drug Administration by the end of 2022. Efgartigimod SC is on track to be the first of Halozyme’s Wave 3 potential partner launches that are projected to occur between 2023 and 2025.
In March 2022, Halozyme and Chugai Pharmaceutical entered into a global collaboration and license agreement for ENHANZE technology. Halozyme received upfront payments of $25 million from Chugai and is eligible to receive additional future payments of up to $160 million, subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also be entitled to receive royalties on sales of commercialized medicines using the ENHANZE technology.
In March 2022, ViiV initiated enrollment of a Phase 1 study to evaluate the safety and pharmacokinetics of N6LS, a broadly neutralizing antibody, administered subcutaneously with ENHANZE technology.
Recent Corporate Highlights:

In April 2022, Halozyme announced the pending acquisition of Antares, extending its revenue growth and durability by expanding its drug-delivery capabilities with the addition of an industry-leading auto-injector platform as well as a commercial business with three proprietary products. The proposed acquisition provides compelling financial and strategic benefits including expected revenue and non-GAAP earnings accretion in 2022 and long-term financial upside, accelerating both top and bottom-line growth. Halozyme expects to build on Antares’ existing platform technology and capabilities to drive incremental, durable revenue opportunities with additional intellectual property protections for Antares technology in place beyond 2030. The acquisition is expected to close in the first half of 2022.
In March 2022, Halozyme announced the appointment of Moni Miyashita to its board of directors. Ms. Miyashita is an accomplished executive with over 25 years of global strategic, mergers & acquisitions and business transformation expertise and currently serves as chief strategy officer of Valo Health.
In February 2022, Halozyme announced the appointment of Nicole LaBrosse as Halozyme’s chief financial officer. Nicole brings over 18 years of public accounting and corporate finance experience to Halozyme and most recently served as Halozyme’s vice president of finance and accounting.
First Quarter Financial Highlights

Revenue for the first quarter was $117.3 million compared to $89.0 million for the first quarter of 2021. The 32% year-over-year increase was primarily driven by an increase in royalty revenue primarily attributable to subcutaneous DARZALEX (daratumumab), partially offset by a decrease in revenues under collaborative agreements. Revenue for the quarter included $69.6 million in royalties, an increase of 89% compared to $36.9 million in the prior year period.
Cost of product sales for the first quarter was $15.9 million, compared to $18.2 million for the first quarter of 2021. The year-over-year decrease, despite an increase in product sales, was primarily driven by the timing of manufacturing overhead costs in the prior year period.
Research and development expenses for the first quarter were $11.9 million, compared to $9.0 million for the first quarter of 2021. The increase is primarily due to an increase in compensation expense, including share-based compensation, for personnel in support of investment in ENHANZE.
Selling, general and administrative expenses for the first quarter were $13.8 million, compared to $11.1 million for the first quarter of 2021. The increase was primarily due to an increase in compensation expense and costs associated with M&A and diligence activities.
Operating Income: On a GAAP basis in the first quarter of 2022, operating income was $75.7 million, compared to an operating income of $50.7 million in the first quarter of 2021.
Net Income: On a GAAP basis in the first quarter of 2022, net income was $60.1 million, compared with net income of $27.9 million in the first quarter of 2021. Non-GAAP net income was $66.1 million in the first quarter of 2022, compared with non-GAAP net income of $54.3 million in the first quarter of 2021.1
Earnings per Share: On a GAAP basis in the first quarter of 2022, diluted earnings per share was $0.43, compared with $0.19 in the first quarter of 2021. On a non-GAAP basis, diluted earnings per share was $0.47, compared with diluted earnings per share of $0.37 in the first quarter of 2021.1
Cash, cash equivalents and marketable securities were $786.1 million on March 31, 2022, compared to $740.9 million on December 31, 2021.
Financial Outlook for 2022

The Company is reiterating its financial guidance for 2022 which was first provided on January 10, 2022. For the full year 2022, the Company expects:

Total revenue of $530 million to $560 million, representing growth of 20%-26% over 2021 total revenue. The Company expects revenue from royalties to increase approximately 50% over revenue from royalties in 2021 to approximately $300 million.
GAAP operating income of $350 million to $380 million, representing growth of 27%-38% over 2021 GAAP operating income, resulting in operating margins greater than 65%.
GAAP net income of $270 million to $295 million; and non-GAAP net income of $290 million to $315 million.1 The Company notes that 2022 will be the first full fiscal year in which Halozyme will record income tax expense as part of its income statement.
GAAP diluted earnings per share of $1.90 to $2.05, inclusive of the first full year of income tax expense, projected to be $0.55-$0.60 per share. In comparison, in 2021 the Company recorded a one-time non-cash income tax benefit of $154.2 million or $1.05 per share, related to the release of its tax valuation allowance.
Non-GAAP diluted earnings per share are expected to be $2.05 to $2.20,1 reflective of the first full year in which the company will record income tax expense, projected to be $0.55-$0.60 per share.
The Company’s financial guidance does not consider the impact of the potential Antares acquisition, and the Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2022 today, Tuesday, May 10, 2022 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website, and a replay will be available following the close of the call. To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, please register a day in advance or at minimum 10 minutes before the start of the call.

On May 10, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the first quarter ended March 31, 2022 (Press release, Cogent Biosciences, MAY 10, 2022, View Source [SID1234614096]).

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"We continue to make significant progress towards our strategic priorities for 2022," said Andrew Robbins, President and CEO of Cogent Biosciences. "We look forward to presenting initial clinical data from our APEX trial of bezuclastinib in advanced systemic mastocytosis patients at the annual EHA (Free EHA Whitepaper) meeting this June. This presentation will include patient data from each dose cohort of bezuclastinib, including levels of serum tryptase, a validated biomarker of mast cell activity. We also continue to enroll patients in the SUMMIT and PEAK trials with bezuclastinib. In addition, our research team has rapidly advanced our pipeline with the addition of our FGFR2 and ErbB2 programs, each with clear differentiation from other programs in development and best-in-class potential. With these important advances, we believe we are well positioned to build on our momentum to bring important therapies to patients with genetically defined diseases."

Upcoming Milestones and Recent Business Highlights

On track to report initial clinical data from APEX, a global, multicenter, Phase 2 clinical trial of bezuclastinib, a potent, highly selective, minimally brain-penetrant KIT mutant inhibitor in patients with Advanced Systemic Mastocytosis (AdvSM) in the second quarter of 2022.
Data to be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Annual Congress will include safety and tolerability from patients across each dose cohort, as well as levels of serum tryptase, a validated biomarker of mast cell activity. The hybrid conference will take place in Vienna, Austria from June 9-12, 2022.

Presented early data and outlined Cogent’s strategy to create best-in-class small molecules from the company’s growing pipeline of novel, targeted therapy programs at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and Cogent R&D investor event.
Advancing a potent, selective FGFR2 inhibitor toward candidate selection with a product profile that includes best-in-class selectivity and potency against all known FGFR2 primary driver and secondary resistance mutations. On track for first internally developed Investigational New Drug application (IND) in the second half of 2023.
Announced development of an ErbB2 mutant selective inhibitor for patients with mutations that are not well addressed by therapies currently approved or in clinical development.

Shared additional nonclinical data demonstrating bezuclastinib’s potential as a best-in-class KIT mutant inhibitor during the 2022 AACR (Free AACR Whitepaper) annual meeting.
Presentations demonstrated bezuclastinib has a unique profile as a potent, mutant KIT inhibitor (including KIT D816V) with minimal brain penetration and no activity against related kinases including PDGFR, FLT3 and CSF1R, which have been linked to off-target toxicities including edema and pleural effusions.

Actively enrolling patients in SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial with bezuclastinib for nonadvanced systemic mastocytosis (NonAdvSM).
SUMMIT is designed to evaluate the safety and efficacy of bezuclastinib in patients with moderate to severe Indolent Systemic Mastocytosis (ISM) or Smoldering Systemic Mastocytosis (SSM).
Actively enrolling patients in PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with Gastrointestinal Stromal Tumors (GIST).
PEAK is designed to evaluate the efficacy and safety of bezuclastinib in combination with sunitinib compared to sunitinib alone in patients with locally advanced, unresectable or metastatic GIST who have received prior treatment with imatinib.
First Quarter 2022 Financial Results

Cash and Cash Equivalents: As of March 31, 2022, cash and cash equivalents were $191.0 million as compared to $219.7 million as of December 31, 2021. Based on its current plans, the company expects that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.

R&D Expenses: Research and development expenses were $25.5 million for the first quarter of 2022 compared to $8.2 million for the first quarter of 2021. The increase was primarily due to costs associated with the on-going APEX, SUMMIT and PEAK clinical trials and costs related to expanding the Cogent Research Team, which was formed in the second quarter of 2021.

G&A Expenses: General and administrative expenses were $5.9 million for the first quarter of 2022 compared to $4.6 million for the first quarter of 2021. The increase was primarily due to the growth of the organization.

Net Loss: Net loss was $30.6 million for the first quarter of 2022 compared to a net loss of $11.7 million for the first quarter of 2021.

On May 10, 2022 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at the following investor conferences in May (Press release, Coherus Biosciences, MAY 10, 2022, View Source [SID1234614112]).

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BofA Securities 2022 Healthcare Conference on Thursday, May 12 at 3:00 p.m. ET
UBS Global Healthcare Conference on Tuesday, May 24 at 2:00 p.m. ET
H.C. Wainwright Global Investment Conference on Wednesday, May 25 at 9:00 a.m. ET
Audio webcasts of these presentations will be available on the investors’ page of the Coherus website at View Source Please access the website prior to the start of the presentation to ensure a timely connection to the webcast. Each webcast will be archived on the Coherus website for 30 days.

On May 10, 2022 Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) has reported that the first patient has been dosed in the ‘STARLITE 2’ Phase II study of Telix Pharmaceuticals Limited (Telix) investigational renal cancer therapy product, TLX250 (177Lu-DOTA-girentuximab), at Memorial Sloan Kettering Cancer Center (MSK) in New York (Press release, Eczacıbaşı-Monrol Nuclear Products, MAY 10, 2022, View Source [SID1234614128]). Monrol supplied Lutetium (Lu-177 n.c.a) to Telix Pharmaceuticals to manufacture clinical doses of TLX250 for STARLITE 2 Phase II study. This collaboration may offer significant opportunities for clear cell renal cell carcinoma (ccRCC) patients in the future.

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The STARLITE 2 Phase II study (NCT05239533) will assess the efficacy of TLX250 targeted radiation in combination with the anti-PD-11 immunotherapy Opdivo2 (nivolumab) for ccRCC, the most common and aggressive form of kidney cancer. The primary endpoint is to determine the safety and efficacy of combination therapy with TLX250 as assessed by the tumours responding to the Telix therapy versus the current standard of care alone. TLX250 targets carbonic anhydrase IX (CA9),3 a protein that is highly expressed in patients that are likely to demonstrate a more limited response to cancer immunotherapy.4 The concept is that low doses of targeted radiation can potentially overcome immune resistance – or "immune prime" a tumour and therefore make it more responsive to cancer immunotherapy. Telix’s investigational companion imaging agent TLX250-CDx (89Zr-DFO-girentuximab) will also be used in the study to image CA9 expression.

Clinical doses of Telix’s investigational renal cancer companion imaging agent TLX250-CDx (89Zr-DFO-girentuximab) is also produced by Eczacıbası Monrol in its Istanbul facility for the Phase III ZIRCON clinical trial.

ZIRCON Phase III study ("Zirconium Imaging in Renal Cancer Oncology") is an international multi-centre study at 34 sites in Europe, Australia, Turkey, Canada, and the United States. The study enrolled 30 patients in Turkey. The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect ccRCC in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth.

Monrol is a company developing, manufacturing, and distributing world-class radiopharmaceutical products, radioisotopes to improve quality of life of cancer patients globally and one of the few producers of Lutetium-177 n.c.a, having uninterrupted worldwide supply capabilities. Monrol Lu-177 n.c.a production process is an exclusive processing technology having cleaner and safer production method with stable isotope enrichment capability.

"Lu-177 n.c.a contributes to our mission to improve quality of life of cancer patients globally. Our new GMP certified facility exclusively designed for theranostic R&D and production with cutting edge technology will enable us to maximize supply of high-quality Lutetium worldwide. We are committed to working closely with Telix to potentially bring new therapeutic radiopharmaceutical agents into market soon to improve patients’ lives having life threatening diseases" said Monrol General Manager Aydin Kucuk".

Telix Chief Medical Officer, Dr. Colin Hayward noted, "The integration of precision nuclear medicine and medical oncology is underway and Telix is at the forefront of this movement to develop personalised products and patient-friendly regimens. We wish to express our gratitude to Dr. Darren Feldman and his clinical team, as well as the patients who will contribute to this ground-breaking study STARLITE 2".

Disclosure: MSK has institutional financial interests related to Telix.

About Lutetium-177 n.c.a

Lutetium-177 n.c.a is a radioisotope of choice for targeted radionuclide therapy. Lu-177 n.c.a production process enables treatment options that have the potential to improve treatment outcomes for certain cancer patients today. Unique properties of Lutetium-177 n.c.a makes it a theranostically desirable radioisotope for peptide receptor radionuclide therapy (PRRT) to treat certain cancers like Neuro Endocrine Tumors (NET), Prostate cancer and many other clinical development programs are ongoing for other cancers like ccRCC.

In line with the company mission to create hope for a better life for cancer patients, Monrol is establishing strategic partnerships with multinational pharmaceutical companies and constructing a new production facility compliant with FDA 21 CFR Part 211 quality standards which will have an annual production capacity of 60 thousand doses. With its location close to Istanbul, a major transportation hub, the new facility will benefit from a worldwide logistics network and agreements with cargo services to 320 destinations worldwide.

About TLX250

TLX250 (177Lu-DOTA-girentuximab) is an antibody-based therapeutic platform that targets carbonic anhydrase IX (CA9), a cell surface protein that is highly expressed in several human cancers including ccRCC. High CA9 tumour expression is generally correlated with poor prognosis.

About TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is being developed by Telix for the purpose of determining whether "indeterminate renal masses", typically identified based on CT or MRI imaging, are either clear cell renal cell cancer (ccRCC) or non-ccRCC, using Positron Emission Tomography (PET) imaging. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx, reflecting the significant unmet clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer. Telix’s companion investigational diagnostic imaging agent TLX250-CDx (89Zr-DFO-girentuximab) is the subject of a global Phase III trial recruiting (ZIRCON trial, NCT03849118).