Werewolf Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update

On May 11, 2023 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 a business update and provided financial results for the first quarter ended March 31, 2023 (Press release, Werewolf Therapeutics, MAY 11, 2023, View Source [SID1234631541]).

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"In the first quarter, Werewolf has focused on execution by progressing our INDUKINE pipeline and enrolling ongoing first-in-human clinical trials for our lead programs, WTX-124 and WTX-330. In addition, preclinical data presented at AACR (Free AACR Whitepaper) and published in Cancer Immunology Research continues to demonstrate the robustness of our PREDATOR platform showing that Werewolf’s conditional activation technology results in potent anti-tumor activity alongside an improved therapeutic index," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "Looking ahead, in the fourth quarter we plan to share initial safety, tolerability, and preliminary efficacy data from our Phase 1/1b clinical trial of WTX-124 in solid tumor types."

"Finally, we’d like to express our deep appreciation to Reid Leonard, Ph.D., Werewolf’s Chief Operating Officer, who is retiring effective June 30, 2023, after a long and successful career in the biopharmaceutical industry. Reid is a founding member of the Werewolf Executive Team and has been instrumental in leading and advancing all aspects of organizational operations. We have benefited greatly from Reid’s significant expertise, and the strong team he has built and business process he has established will ensure continued operational excellence going forward. We wish Reid the very best in his retirement."

Recent Highlights and Upcoming Milestones

WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule being developed as monotherapy and in combination with checkpoint inhibitor therapy in multiple solid tumor types.

•Werewolf is progressing Study WTX-124×2101, its Phase 1/1b, multi-center, open-label clinical trial evaluating WTX-124 as a monotherapy and in combination with KEYTRUDA (pembrolizumab) in patients with immunotherapy sensitive advanced or metastatic solid tumors who have failed standard of care, including checkpoint inhibitor therapy.
•Enrollment is ongoing in monotherapy dose-escalation cohorts, and the Company anticipates reporting interim safety, tolerability and preliminary efficacy data from these monotherapy cohorts in the fourth quarter of 2023.

•During the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023, the Company presented a poster entitled "Trial in progress: a multicenter phase 1/1b dose escalation study of WTX-124 as a monotherapy and in combination with pembrolizumab in patients with selected advanced or metastatic solid tumors."

WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in refractory and/or immunologically unresponsive tumors.

•Werewolf is progressing Study WTX-330×2101, its Phase 1, multi-center, open-label trial evaluating WTX-330 as a monotherapy in patients with immunotherapy insensitive or resistant advanced or metastatic solid tumors or non-Hodgkin lymphoma. Enrollment is ongoing in dose-escalation.
•During the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023, the Company presented a poster entitled "Trial in progress: a first-in-human, phase 1, multicenter dose escalation and dose expansion study of WTX-330 in adult patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma."
•Also in April 2023, the Company announced the publication of preclinical data in Cancer Immunology Research Online First, demonstrating that mWTX-330 delivers IL-12 selectively to the tumor environment to inhibit tumor growth in mouse models. The preclinical data demonstrate that mWTX-330 stimulates a potent anti-tumor response in mice by activating tumor infiltrating lymphocytes and restoring the metabolic health of these lymphocytes and has the potential to minimize the toxicity previously associated with systemic IL-12 administration.

Early-Stage Pipeline:
•During the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023, The Company presented a poster entitled "Generation of IL-21 INDUKINE molecules for the treatment of cancer," which featured preclinical data supporting the recent nomination of Werewolf’s third wholly owned candidate, WTX-712, a conditionally activated IL-21 INDUKINE molecule in development for treatment of cancer. Highlights of the presentation include:
◦IL-21 INDUKINE polypeptides demonstrated improved tolerability and therapeutic window in mouse syngeneic tumor models.
◦Efficacy in these tumor models was linked to expansion and activation of tumor infiltrating T cells, increased polyfunctionality in CD8+ T cells, and signs of increased activation of B cells.

Financial Results for the First Quarter of 2023:

•Cash position: As of March 31, 2023, cash and cash equivalents were $147.9 million, compared to $129.3 million as of December 31, 2022. The Company also has restricted cash and cash equivalents of $21.2 million, compared to $1.2 million as of December 31, 2022. These increases are primarily due to proceeds from the Company’s at-the-market sales facility, the drawdown of remaining capital available under its term loan agreement with Pacific Western Bank, and funding received in connection with the Company’s licensing agreement with Jazz Pharmaceuticals ("Jazz"). The Company expects that its existing cash and cash equivalents, together with anticipated collaboration revenue, will be sufficient to fund its operational expenses and capital expenditure requirements through at least the fourth quarter of 2024.
•Collaboration revenue: Collaboration revenue was $4.5 million for the first quarter of 2023, compared to zero for the same period in 2022. Collaboration revenue is related to partial recognition 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 $11.7 million for the first quarter of 2023, compared to $10.9 million for the same period in 2022. The increase in research and development expenses was primarily due to increased personnel costs.
•General and administrative expenses: General and administrative expenses were $5.0 million for the first quarter of 2023, compared to $4.4 million for the same period in 2022. The increase in general and administrative expenses was primarily due to increased costs to support the increasing size and complexity of Werewolf’s research, development and manufacturing activities.
•Net loss: Net loss was $12.0 million for the first quarter of 2023, compared to $15.3 million for the same period in 2022.

UroGen Pharma Meets Revenue Goal, Reports First Quarter 2023 Financial Results and Recent Corporate Developments

On May 11, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the first quarter ended March 31, 2023, and provided an overview of recent developments (Press release, UroGen Pharma, MAY 11, 2023, View Source [SID1234631540]).

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"2023 is off to a promising start as we reported double-digit year-over-year growth in worldwide JELMYTO net sales during the first quarter," said Liz Barrett, President, and Chief Executive Officer of UroGen. "JELMYTO adoption continues to grow, attributable to the growing body of evidence supporting its benefits in a real-world setting, combined with key initiatives that have expanded access and improved logistical efficiencies for physicians and patients. As we look ahead to summer 2023, we have several key events to prepare for, primarily topline results from both the ENVISION and ATLAS clinical trials investigating the potential of UGN-102 for the treatment of LG-IR-NMIBC. With prospective favorable results, we will look to submit a New Drug Application (NDA) for UGN-102 in 2024 to the U.S. Food & Drug Administration (FDA), for which we are already actively preparing."

Business Highlights:

UGN-102 (mitomycin) for intravesical solution:

A topline data readout of the primary endpoint from the ENVISION Phase 3 pivotal study of UGN-102 evaluating the complete response (CR) rate of ~240 patients at 3-months after first instillation is expected this summer.
Topline data from the ATLAS clinical trial, the predecessor to ENVISION, is expected summer 2023 and will evaluate complete response, duration of response and safety from ~280 patients that completed the trial.
Announced preliminary results of a study to assess the feasibility of home instillation of UGN-102. In this study, UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% (n=8) of patients achieving a complete response, defined as no detectable disease 3 months after starting treatment.
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC):

Generated net product revenue of $17.2 million for the first quarter of 2023, representing ~27% growth over the first quarter of 2022.
Activated sites on May 1, 2023 were 1,009, compared to 983 on March 1, 2023, while repeat accounts on May 1, 2023 were 235, compared to 214 on March 1, 2023.
A positive American Urologic Association (AUA) meeting was headlined by the first ever AUA and Society of Urologic Oncology (SUO) treatment guideline for LG-UTUC, recommending use of JELMYTO in certain clinical scenarios. The guideline states that tumor ablation should be the initial management option for patients with low-risk favorable UTUC, for which JELMYTO can be a treatment option as part of a kidney sparing approach intended to prevent radical nephroureterectomies (RNU) in low-risk UTUC patients.
New retrospective study presented at AUA 2023 reported on the use of JELMYTO in treating patients with UTUC after complete endoscopic ablation. Patients in this retrospective study who underwent complete endoscopic ablation followed by JELMYTO were more likely to be disease-free at first endoscopic evaluation than those who underwent chemoablation alone (69% vs. 40%). In the Phase 3 OLYMPUS study of JELMYTO, LG-UTUC patients in the primary chemoablation setting achieved a 58% complete response rate at first endoscopic evaluation.
New retrospective study presented at AUA 2023 reported similar outcomes when utilizing Jelmyto in treating LG-UTUC of the ureter compared to renal pelvic cancers. In this analysis, 47 patients had UTUC tumors involving the ureter, with 12 cases of ureteral tumor only (8.8%) and 35 cases of ureteral plus renal pelvic tumors (25.7%). The investigators reported no difference in outcomes at first endoscopic evaluation based on tumor location (p=0.644). JELMYTO is approved for the chemoablation of low-grade upper tract urothelial cancer (LG-UTUC) involving the renal pelvis and calyces.
First Quarter 2022 Financial Results:

Jelmyto Revenue: UroGen reported net product revenue of Jelmyto for the first quarter 2023 of $17.2 million, compared to $13.6 million in the first quarter of 2022.

R&D Expense: Research and development expenses for the first quarter 2023 were $12.5 million, including non-cash share-based compensation expense of $0.5 million as compared to $12.7 million, including non-cash share-based compensation expense of $0.7 million, for the same period in 2022.

SG&A Expense: Selling, general and administrative expenses for the first quarter 2023 were $24.5 million, including non-cash share-based compensation expense of $1.8 million. This compares to $21.3 million, including non-cash share-based compensation expense of $2.2 million, for the same period in 2022.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $5.2 million for the first quarter 2023. The rate applied to cash payments incurred in 2023 is 13% based on global net product sales of JELMTYO in 2022.

Interest Expense on Long-Term Debt: Interest expense related to the $100 million term loan facility with funds managed by Pharmakon Advisors was $3.6 million for the first quarter of 2023, compared to $0.3 million for the same period last year due to the transaction closing in March 2022 and the final $25 million draw down under the term loan facility in December 2022.

Net Loss: UroGen reported a net loss of $30.2 million, or basic and diluted net loss per ordinary share of $1.30, for the first quarter 2023 as compared to $28.4 million, or basic and diluted net loss per ordinary share of $1.25, for the same period in 2022.

Cash & Cash Equivalents: As of March 31, 2023, cash, cash equivalents and marketable securities totaled $75.2 million.

2023 Revenue, Operating Expense and RTW Expense Guidance: The Company reiterates anticipated full year 2023 net product revenues from JELMYTO to be in the range of $76 to $86 million. The Company reiterates anticipated full year 2023 operating expenses in the range of $135 to $145 million, including non-cash share-based compensation expense of $6.0 to $11.0 million, subject to market conditions. The Company reiterates anticipated full year 2023 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $21.0 to $26.0 million. Of this amount approximately $9.9 to $11.2 million is expected to be in cash.

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

Theseus Pharmaceuticals Announces Business Highlights and Reports First Quarter 2023 Financial Results

On May 11, 2023 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 highlights and provided financial results for the first quarter ended March 31, 2023 (Press release, Theseus Pharmaceuticals, MAY 11, 2023, View Source [SID1234631539]).

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"We look forward to continued clinical execution and important pipeline advancements in the months ahead, most notably with two anticipated clinical readouts from our lead program, THE-630, in advanced GIST," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "We maintain a strong financial position as we continue to progress our pipeline, with an anticipated IND submission for THE-349 in the fourth quarter of this year as well as advancement of our BCR-ABL and discovery programs."

Recent Pipeline Highlights and Upcoming Expected Milestones:

THE-630 is a pan-variant tyrosine kinase inhibitor (TKI) of the receptor tyrosine kinase KIT, designed for patients with gastrointestinal stromal tumors (GIST) that have developed resistance to earlier lines of therapy.
•As of March 31, 2023, Theseus is enrolling patients in cohort 7 of its ongoing phase 1/2 dose escalation and expansion clinical trial evaluating THE-630 in patients with advanced GIST.

•Theseus submitted its initial dose escalation results to the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, in Chicago, Illinois, and the abstract was selected for online publication. Theseus plans to present data with an updated cutoff date during a virtual investor event on May 25, 2023, at 5:30pm ET, after the public release of the abstract. The initial dose escalation data will include preliminary safety, pharmacokinetic (PK), and clinical activity data through cohort 6, as well as an analysis of circulating tumor DNA (ctDNA) through cohort 5.

•Theseus plans to present follow-up data at a scientific conference in the fourth quarter of 2023, which is expected to include data from additional dose escalation cohorts, including cohort 8, where Theseus expects to have reached the target systemic exposure for pan-variant KIT activity.

THE-349 is a fourth-generation (4G) epidermal growth factor receptor (EGFR) TKI development candidate, which has demonstrated activity against single-, double-, and triple-mutant EGFR variants, including T790M and C797X, found in EGFR-mutant non-small cell lung cancer (NSCLC) that has developed resistance to first- or later-line osimertinib.
•Preclinical data demonstrate THE-349 can potently inhibit all major classes of EGFR activating and resistance mutations observed in a post-first- or later-line osimertinib setting, possesses kinome and wild-type EGFR selectivity, and has central nervous system (CNS) activity.

•Theseus expects to submit an Investigational New Drug Application (IND) for THE-349 to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023 and to initiate the first-in-human trial as soon as possible thereafter, subject to clearance of the IND by the FDA.

BCR-ABL Program: Theseus aims to develop a potent and selective, next-generation, pan-variant BCR-ABL TKI candidate that optimizes the balance of safety and efficacy for patients with relapsed/refractory chronic

myelogenous leukemia (CML) and patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

•Preclinically, Theseus lead molecules have been observed to show a high degree of potency against BCR-ABL and clinically relevant resistance mutations, such as the T315I gatekeeper mutation, and substantial kinome selectivity.
•Theseus expects to nominate a development candidate for this program by early 2024, with the goal of pursuing clinical development in patients with CML who have been previously treated with a second-generation TKI or have the T315I mutation, and in newly diagnosed patients with Ph+ ALL.

Business Highlights:

•In May 2023, Theseus announced the appointment of Franklin Vairinhos, Ph.D., as Vice President, Regulatory Affairs. Dr. Vairinhos has more than 30 years of experience in Regulatory Affairs, predominantly in developing regulatory strategies for oncology therapies.

First Quarter Financial Results:

Cash Position: As of March 31, 2023, Theseus had cash, cash equivalents, and marketable securities of $243.6 million, as compared to $211.8 million as of December 31, 2022. Theseus expects its current cash, cash equivalents, and marketable securities to fund operations and capital expenditures into the third quarter of 2025 based on its current operating plan.

R&D Expenses: Research and development expenses were $12.4 million for the first quarter of 2023, as compared to $6.5 million for the same period in 2022. This increase was primarily due to a $2.7 million increase in expense for preclinical studies and drug manufacturing to support THE-349 IND enabling studies, a $1.4 million increase in development expense related to discovery programs, as well as a $1.5 million increase in employee-related costs driven by an increase in headcount.

G&A Expenses: General and administrative expenses were $4.7 million for the first quarter of 2023, as compared to $4.0 million for the same period in 2022. This increase was primarily due to an increase in stock-based compensation expense and employee-related costs.

Net Loss: Net loss was $14.6 million for the first quarter of 2023, as compared to a net loss of $10.5 million for the same period in 2022.

TCR2 Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update

On May 11, 2023 TCR2 Therapeutics Inc. (Nasdaq: TCRR) (TCR2 or the Company), a clinical-stage cell therapy company with a pipeline of novel next-generation T cell therapies for patients suffering from solid tumors, reported financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, TCR2 Therapeutics, MAY 11, 2023, View Source [SID1234631538]).

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"We are pleased with our continued progress during the last quarter which included the announcement of the strategic combination of TCR2 with Adaptimmune. We believe that the integration of the two companies’ complimentary technology platforms and pipelines focused on treating solid tumors has the potential to fundamentally change the war on cancer," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics.

Recent Developments


TCR2 announced a strategic combination with Adaptimmune Therapeutics plc (Adaptimmune) to create a preeminent cell therapy company for solid tumors. The two companies entered into a definitive agreement under which Adaptimmune will combine with TCR² in an all-stock transaction. The transaction is expected to close in the second quarter of 2023, subject to approval by TCR2 stockholders and Adaptimmune shareholders and satisfaction or waiver of other closing conditions. Following the closing of the transaction, Adaptimmune shareholders will own approximately 75% and TCR² stockholders will own approximately 25% of the combined company. As a result, and following the closing of the transaction, it is anticipated that the combined company’s cash runway will extend into 2026. A special meeting of TCR2 stockholders to approve the merger with Adaptimmune will be held on May 30, 2023. Proxy materials and voting instructions have been made publicly available. Please call TCR2’s proxy solicitor, Innisfree M&A Incorporated, at (877) 750-8233, with any questions.

TCR2 presented Phase 1 gavo-cel data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting and published preclinical gavo-cel data in OncoImmunology.

Financial Highlights


Cash Position: TCR2 ended the first quarter of 2023 with $110.3 million in cash, cash equivalents, and investments compared to $149.2 million as of December 31, 2022. Net cash used in operations was $40.0 million for the first quarter of 2023 compared to $31.1 million for the first quarter of 2022.

R&D Expenses: Research and development (R&D) expenses were $29.2 million for the first quarter of 2023 compared to $22.3 million for the first quarter of 2022. The increase in R&D expenses was primarily due to an increase in clinical trial expenses associated with patient treatment and product manufacturing.

Impairment and Restructuring Expenses: Impairment expenses were $4.0 million for the first quarter of 2023 compared to $0.6 million for the first quarter of 2022. The increase in impairment expenses for the first quarter includes $2.1 million in severance and related costs and $1.9 million in charges related to construction in progress and certain laboratory equipment.

G&A Expenses: General and administrative expenses were $8.2 million for the first quarter of 2023 compared to $6.3 million for the first quarter of 2022. The increase in general and administrative expenses for the first quarter includes $3.6 million in transactions costs related to the proposed transaction with Adaptimmune.

Net Loss: Net loss was $40.4 million for the third quarter of 2023 compared to $29.1 million for the first quarter of 2022.

About gavo-cel, TC-510, and TC-520

Our most advanced program, gavo-cel, targets tumors that express the protein mesothelin.

TC-510 is an enhanced version of gavo-cel that co-expresses a PD-1:CD28 chimeric switch receptor that the Company believes may lead to deeper responses and more durable benefit.

TC-520 is the Company’s first TRuC-T cell targeting CD-70-expressing solid and liquid tumors which incorporates IL-15 pathway enhancements designed to improve T-cell persistence. TCR2 is currently advancing TC-520 to Investigational New Drug (IND) status.

Synlogic Reports First Quarter 2023 Financial Results and Provides Business Update

On May 11, 2023 Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, reported its financial results for the first quarter ended March 31, 2023, and provided an update on its pipeline programs (Press release, Synlogic, MAY 11, 2023, View Source [SID1234631537]).

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"We continue to advance the SYNB1934 program towards initiation of our pivotal study, Synpheny-3, in the first half of the year, focused on our opportunity to transform the medical management of PKU," said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. "The quarter also included recognition of Synthetic Biotics as novel biotherapeutics for rare metabolic diseases more broadly, as both our PKU and homocystinuria (HCU) programs were spotlighted at the leading medical congress for inborn errors of metabolism."

First Quarter 2023 and Recent Business Highlights

Received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA) for SYNB1934 for PKU
Received positive opinion on orphan designation from the European Medicines Agency (EMA) for SYNB1934 for PKU
Announced full data from both the Phase 2 Synpheny-1 study in PKU and the Phase 1 study in HCU at the Society for Inherited Metabolic Disorders (SIMD) 44th Annual Meeting
Anticipated Upcoming Milestones

Initiation of Phase 3 clinical trial of SYNB1934 for PKU in the first half of 2023
Advancing SYNB1353 to Phase 2 study in patients with HCU
Progression of preclinical pipeline programs, including partnerships
First Quarter 2023 Financial Results

As of March 31, 2023, Synlogic had cash, cash equivalents and short-term investments of $57.4 million.

Revenue was $0.2 million for each of the three months ended March 31, 2023 and March 31, 2022. Revenue in both periods was primarily associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease.

For the three months ended March 31, 2023, Synlogic reported a consolidated net loss of $15.6 million, or $0.23 per share, compared to a consolidated net loss of $15.7 million, or $0.22 per share, for the corresponding period in 2022.

Research and development expenses were $12.5 million for the three months ended March 31, 2023, compared to $11.7 million for the corresponding period in 2022.

General and administrative expenses were $4.0 million for the three months ended March 31, 2023, compared to $4.3 million for the corresponding period in 2022.

Financial Outlook

Based upon its current operating plan and balance sheet as of March 31, 2023, Synlogic expects to have sufficient cash to be able to fund operations into the second half of 2024.

Upcoming Investor and Industry Conference Participation

Synlogic leadership will attend the Jefferies Global Healthcare Conference being held June 7-9, 2023, in New York City.