On August 8, 2024 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported that it has entered into a strategic financing agreement with Sixth Street for significant, long-term, non-dilutive capital to fund innovation and growth opportunities across Arrowhead’s robust and diverse pipeline of RNAi therapeutics (Press release, Arrowhead Pharmaceuticals, AUG 8, 2024, View Source [SID1234645642]). The $500 million senior secured credit facility includes $400 million funded at close with an additional $100 million available at Arrowhead’s option, subject to mutual agreement between Sixth Street and Arrowhead, during the seven-year term of the agreement.

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"This deal and its favorable structure and economics allow us to confidently build our commercial capabilities to support our first commercial launch in 2025, provided we receive regulatory approval for plozasiran in familial chylomicronemia syndrome. This transaction is non-dilutive and has an attractive repayment structure, which largely aligns outflows with future inflows, allowing us to keep more cash in the business at a critical time of growth. In addition, because of the flexible repayment mechanics during the seven-year term, it has important risk sharing features. Not only does the facility allow us to support plozasiran as we move toward a commercial launch, it also expands our ability to fund growth and innovation across our pipeline," said Christopher Anzalone, Ph.D., President and CEO at Arrowhead.

Jeff Pootoolal, Partner at Sixth Street and Michael Reslinski, Managing Director added, "Arrowhead Pharmaceuticals has an impressive platform technology, attractive pipeline assets with promising commercial opportunities, and multiple partnerships maturing toward commercialization. We are pleased to utilize our firm’s scale, expertise and flexibility to help Arrowhead meet its strategic objectives through this innovative financing solution, and we hope to continue strengthening our relationship with the company as it rapidly becomes one of the most exciting emerging commercial-stage biopharmaceutical companies."

The credit facility matures on August 7, 2031, and bears interest at an annual rate of 15%. The credit facility does not provide for scheduled amortization payments during the term, and all principal will be due on the Maturity Date. Arrowhead will have the right to prepay loans under the credit facility at any time. The company is required to partially repay loans under the credit facility with a portion of the proceeds from certain transactions, such as the future collection of upfront payments, milestones, and royalties from partnerships and collaborations, and commercial revenue by Arrowhead. All obligations will be secured on a first-priority basis, subject to certain exceptions, by security interests in substantially all assets of the company.

TD Cowen acted as financial advisor and Gibson, Dunn & Crutcher LLP served as legal advisor to Arrowhead. Proskauer Rose LLP and Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, PC acted as legal advisors to Sixth Street.

On August 8, 2024 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the second quarter ended June 30, 2024, and provided a business update (Press release, Altimmune, AUG 8, 2024, View Source [SID1234645641]).

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"During the second quarter, we continued to highlight the scientific evidence supporting the robust therapeutic potential of pemvidutide in metabolic diseases," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "The data presented at the European Association for the Study of the Liver (EASL) meeting highlighted the disease-modifying potential of pemvidutide in MASH and reinforces our confidence in achieving success on the MASH resolution and fibrosis improvement endpoints of our Phase 2b IMPACT trial. We also delivered two podium presentations at the American Diabetes Association (ADA) 84th Scientific Sessions that highlighted the robust reductions in body weight and serum lipids with pemvidutide treatment. In addition, we presented data demonstrating class-leading preservation of lean mass among incretin agents, an increasingly important consideration in the treatment of obesity. These data further exemplify the differentiation and broad utility we believe pemvidutide will bring to the rapidly evolving obesity marketplace. We continue to make progress toward expanding the development of pemvidutide in up to three additional indications where its dual GLP-1/glucagon agonism could provide benefit over currently available agents. In parallel with these efforts, our discussions with potential strategic partners continue to progress. We look forward to sharing further updates on each of these initiatives."

Recent Highlights and Anticipated Milestones:

Obesity:

On June 22 and 23, the Company presented data from its Phase 2 MOMENTUM obesity trial at the American Diabetes Association’s (ADA) 84th Annual Scientific Sessions
At 48 weeks of treatment, subjects receiving pemvidutide achieved weight loss of up to 15.6% with weight loss continuing at the end of treatment.
A full analysis of body composition data showed class-leading lean mass preservation among incretin agents with only 21.9% of weight loss attributable to lean mass and 78.1% attributable to fat.
Treatment with pemvidutide also resulted in robust reductions of triglycerides (55.8%), total cholesterol (20.0%) and LDL cholesterol (17.4%) in subjects with elevated baseline lipids on the 2.4mg dose.
In addition, data from the Phase 1 first-in-human trial of pemvidutide demonstrated robust reductions in pro-inflammatory lipids associated with atherogenesis and cardiovascular risk.
End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) expected to take place in late Q3 2024
The Company is seeking agreement from the Agency on the Phase 3 trial design and study endpoints that highlight the differentiation of pemvidutide in the treatment of obesity, including its ability to reduce serum lipids and liver fat content (LFC) and its class-leading preservation of lean mass among incretin agents.
Metabolic Dysfunction-Associated Steatohepatitis (MASH):

On June 5, Altimmune presented data at the EASL International Liver Congress 2024, supporting the disease-modifying potential and differentiated therapeutic profile of pemvidutide in MASH
An analysis of data in our Phase 1 trial of metabolic-associated steatotic liver disease (MASLD) demonstrated that higher proportions of subjects receiving pemvidutide achieved FibroScan-aspartate aminotransferase (FAST) score, MRI-PDFF and alanine aminotransferase (ALT) responses than subjects receiving placebo, suggesting significant rates of MASH resolution and fibrosis improvement may be achieved in the IMPACT Phase 2b MASH trial.
A quantitative systems pharmacology (QSP) computational model predicted that GLP-1/glucagon dual agonism of pemvidutide would have more potent effects on MASH resolution and fibrosis improvement than GLP-1 therapy alone and that both endpoints would be achieved within the 24-week efficacy readout of the IMPACT trial.
Lipidomic profiling showed significant reductions in serum lipids associated with cardiovascular disease, reinforcing our belief in the disease-modifying potential of pemvidutide on MASH-associated cardiovascular co-morbidities.
On July 25, data from the previously reported 12-week clinical trial of pemvidutide in MASLD was published in the Journal of Hepatology
The Phase 1 trial, which enrolled 94 subjects, evaluated three doses of pemvidutide versus placebo administered once weekly for 12 weeks.
Pemvidutide-treated subjects achieved up to 68.5% relative reduction in LFC, an important predictor of MASH resolution and fibrosis improvement, compared to 4.4% in subjects receiving placebo, with up to 55.6% of pemvidutide-treated subjects achieving LFC normalization.
LFC changes were accompanied by significant improvements in body weight and non-invasive markers of liver inflammation.
The adverse event discontinuation rate was only 2.9% in subjects receiving pemvidutide with no severe or serious adverse events reported.
The Company continues to advance IMPACT, its biopsy-driven Phase 2b trial of pemvidutide in MASH
The trial expects to enroll approximately 190 subjects with and without type 2 diabetes (T2D), randomized to receive 1.2mg or 1.8mg of pemvidutide or placebo.
The primary efficacy measures are MASH resolution or fibrosis improvement at Week 24.
The biopsy readout at Week 24 represents the earliest time point of any incretin-based MASH clinical trial.
Financial Results for the Three Months Ended June 30, 2024

Altimmune had cash, cash equivalents and short-term investments totaling $164.9 million on June 30, 2024.
Research and development expenses were $21.2 million for the three months ended June 30, 2024, compared to $13.3 million in the same period in 2023. The expenses for the quarter ended June 30, 2024, included $13.8 million in direct costs related to development activities for pemvidutide and $1.0 million in direct costs related to winddown and closing of our HepTcell program as announced on March 27, 2024.
General and administrative expenses were $5.6 million for the three months ended June 30, 2024, compared to $4.8 million in the same period in 2023. The increase was primarily due to a $1.0 million increase in stock compensation expense caused by modifications of stock awards.
Interest income for the three months ended June 30, 2024, was $2.2 million as compared to $1.8 million in the same period in 2023, primarily due to an increase in interest income earned on cash equivalents and short-term investments.
Net loss for the three months ended June 30, 2024, was $24.6 million, or $0.35 net loss per share, compared to a net loss of $16.1 million, or $0.32 net loss per share, in the same period in 2023.

On August 8, 2024 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the second quarter ended June 30, 2024 (Press release, Xilio Therapeutics, AUG 8, 2024, View Source [SID1234645629]).

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"This quarter, we continued to make meaningful progress advancing our clinical-stage pipeline toward key data milestones and potential value drivers anticipated later this year," said René Russo, Pharm.D., president and chief executive officer of Xilio. "We recently initiated enrollment in our Phase 2 trial of XTX101 in combination with atezolizumab in patients with MSS CRC and our Phase 1 monotherapy dose expansion for XTX301 in patients with advanced solid tumors, and we look forward to reporting clinical data for each of these programs in the fourth quarter. Beyond our clinical-stage pipeline, we are also advancing multiple research-stage programs leveraging our tumor-activated approach for masked immune cell engagers."

Dr. Russo continued, "I am excited to announce the promotion of Chris Frankenfield to chief financial officer of Xilio. Chris’ strategic, financial and operational expertise, together with his collaborative approach and experience building companies, will be instrumental in advancing our pipeline of novel tumor-activated immuno-oncology therapies."

Pipeline and Business Updates

XTX101: tumor-activated anti-CTLA-4

XTX101 is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 designed to block CTLA-4 and deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME).

● Xilio reported the initiation of enrollment in its Phase 2 clinical trial of XTX101 in combination with atezolizumab in patients with MSS CRC, including patients with and without liver metastases. The trial will evaluate the safety and efficacy of XTX101 at 100 mg every six weeks (Q6W) in combination with atezolizumab at 1200 mg every three weeks (Q3W).
● Xilio expects to report initial Phase 2 data for XTX101 in combination with atezolizumab in approximately 20 patients with MSS CRC in the fourth quarter of 2024 and in approximately 20 additional patients (40 patients total) in the first quarter of 2025.

XTX301: tumor-activated, engineered IL-12

XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic "cold" tumors towards an inflamed, or "hot," state.

● Xilio reported the initiation of enrollment in Phase 1B monotherapy dose expansion of its ongoing Phase 1 clinical trial of XTX301 in patients with advanced solid tumors. In addition, enrollment in monotherapy dose escalation for XTX301 is ongoing, with XTX301 currently being evaluated at a dose level of 60 ug/kg Q6W (preceded by a single priming dose of 15 ug/kg). To date, XTX301 has been generally well-tolerated, with no dose-limiting toxicities observed in patients.
● Xilio expects to report safety, pharmacokinetic and pharmacodynamic data from the ongoing Phase 1 clinical trial for XTX301 in the fourth quarter of 2024.

Tumor-activated bispecific and immune cell engager programs

● Xilio is advancing a pipeline of research-stage tumor-activated bispecifics and immune cell engagers, including tumor-activated cell engagers and tumor-activated effector-enhanced cell engagers, leveraging the company’s masking technology.

Corporate Updates

● Xilio reported the promotion of Chris Frankenfield to chief financial officer. Mr. Frankenfield will also continue to serve in his current role as chief operating officer.
● In June 2024, Xilio announced the appointments of Aoife Brennan, M.D., and James Shannon, M.D., to its board of directors.

Second Quarter 2024 Financial Results

● Cash Position: Cash and cash equivalents were $74.9 million as of June 30, 2024, compared to $44.7 million as of December 31, 2023. Cash and cash equivalents as of June 30, 2024 included the $30.0 million upfront payment under the company’s license agreement with Gilead Sciences, Inc. (Gilead) for XTX301, approximately $28.1 million in gross proceeds from the sale and issuance of common stock and prefunded warrants to certain existing accredited investors and Gilead in private placements and $7.0 million in gross proceeds from the sale and issuance of common stock under the company’s at-the-market offering program.
● License Revenue: License revenue was $2.4 million for the quarter ended June 30, 2024, which was associated with revenue recognized under the license agreement and stock purchase agreement with Gilead. No license revenue was recognized prior to the quarter ended June 30, 2024.
● Research & Development (R&D) Expenses: R&D expenses were $11.2 million for the quarter ended June 30, 2024, compared to $13.2 million for the quarter ended June 30, 2023. The decrease was primarily driven by decreased manufacturing activities for XTX301, decreased clinical development activities for XTX202, decreased spending related to early-stage programs and indirect research and development costs and decreased personnel-related costs, partially offset by a $1.0 million development milestone payment to WuXi Biologics (Hong Kong) Limited under the company’s CTLA-4 monoclonal antibody license agreement, and increased clinical development activities for XTX101 and XTX301.

● General & Administrative (G&A) Expenses: G&A expenses were $5.8 million for the quarter ended June 30, 2024, compared to $6.9 million for the quarter ended June 30, 2023. The decrease was primarily driven by decreased personnel-related costs, decreased professional and consulting fees, lower costs related to directors’ and officers’ liability insurance and a reduction in other general and administrative expenses.
● Net Loss: Net loss was $13.9 million for the quarter ended June 30, 2024, compared to $19.4 million for the quarter ended June 30, 2023.
Financial Guidance

Based on its current operating plans, Xilio anticipates that its existing cash and cash equivalents as of June 30, 2024 will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2025.

About XTX101 (anti-CTLA-4) and the Phase 1/2 Combination Clinical Trial

XTX101 is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated (unmasked) in the tumor microenvironment. In the third quarter of 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate XTX101 in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety and efficacy of the combination in a Phase 2 clinical trial in patients with microsatellite stable colorectal cancer. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

About XTX301 (IL-12) and the Phase 1 Clinical Trial

XTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. for Xilio’s tumor-activated IL-12 program, including XTX301. Xilio is currently evaluating the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors in a first-in-human, multi-center, open-label Phase 1 clinical trial. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.

On August 8, 2024 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the second quarter of 2024 and provided an overview of its clinical programs and anticipated milestones (Press release, Vincerx Pharma, AUG 8, 2024, View Source [SID1234645628]).

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"During the second quarter, our team focused on execution and the continued enrollment of patients in our ongoing Phase 1 studies for our potentially best-in-class ADC, VIP943, and first-in-class SMDC, VIP236," said Ahmed Hamdy, M.D., Chief Executive Officer. "We look forward to evaluating the results from additional cohorts and sharing data by end of Q3 for VIP236 and by end of year for VIP943."

SECOND QUARTER 2024 CLINICAL PROGRAM HIGHLIGHTS AND ANTICIPATED MILESTONES

VIP943

VIP943, a novel CD123-targeted ADC created from Vincerx’s VersAptx platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with Vincerx’s CellTrapper technology. Its next-generation effector chemistry was designed to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities.
Vincerx expects to share additional Phase 1 study data for VIP943 for patients with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) (NCT06034275) by the end of Q4 2024.
VIP236

VIP236 is an αVβ3 SMDC conjugated to an optimized camptothecin (CPT) payload created from Vincerx’s VersAptx platform. VIP236 is a first-in-class drug designed to deliver its optimized CPT payload directly to tumor tissues to overcome chemotherapy-related side effects. Preclinical studies have shown 11 times more optimized CPT is delivered to the cancerous tissues than found circulating in the blood. In addition, the optimized CPT is designed to limit drug transporter liabilities, a common mechanism for cancer resistance to chemotherapy.
Vincerx looks forward to sharing additional data from this Phase 1 study (NTC05371054) by the end of Q3 2024.
Enitociclib

Enitociclib is a highly selective CDK9 inhibitor designed to block the activation of RNA polymerase II, leading to the reduction of oncogenes, including MYC and MCL1.
Enitociclib is currently in a Phase 1 dose-escalation study (NTC05371054) evaluating the combination of enitociclib, venetoclax and prednisone in diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). This study is being conducted in collaboration with the National Institutes of Health (NIH).
At the AACR (Free AACR Whitepaper) Advances in Malignant Lymphoma meeting in June 2024, the NIH presented the interim study results previously shared by Vincerx in January 2024 and May 2024.
VIP924

VIP924 is a first-in-class CXCR5-targeted ADC created from Vincerx’s VersAptx platform.
VIP924 can be evaluated in B-cell malignancies, including mantle cell lymphoma, follicular lymphoma, DLBCL, and chronic lymphocytic leukemia , as a monotherapy and in combination.
IND application is anticipated in early 2026, pending funding.
VersAptx Platform

VersAptx is Vincerx’s versatile and adaptable, next-generation bioconjugation platform. The modular nature of this platform enables the combination of different targeting, linker, and payload technologies to develop bespoke bioconjugates to address different cancer biologies.
SECOND QUARTER 2024 FINANCIAL RESULTS

Vincerx had approximately $16.3 million in cash, cash equivalents and marketable securities as of June 30, 2024, as compared to approximately $5.1 million as of March 31, 2024. Based on its current business plans and assumptions, Vincerx believes its available capital, including the proceeds of its April financing of approximately $16.9 million, will be sufficient to meet its operating requirements through the end of 2024.
Research and development expenses for the second quarter ended June 30, 2024 were approximately $3.8 million, as compared to approximately $8.2 million for the same period in 2023. This decrease is primarily the result of decreases in research services of approximately $1.8 million, manufacturing services associated with our ADC program of approximately $1.6 million, and personnel related expenses of approximately $0.8 million.
General and administrative expenses for the second quarter ended June 30, 2024 were approximately $3.6 million, as compared to approximately $3.8 million for the same period in 2023. This decrease is primarily driven by decreases in personnel-related expenses of approximately $0.3 million.
For the second quarter ended June 30, 2024, Vincerx reported a net loss of approximately $1.8 million, or $0.05 per share. For the second quarter ended June 30, 2023, Vincerx reported a net loss of approximately $11.6 million, or $0.54 per share.

On August 8, 2024 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 and other immune-mediated conditions, reported a business update and provided financial results for the second quarter ended June 30, 2024 (Press release, Werewolf Therapeutics, AUG 8, 2024, View Source [SID1234645627]).

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"We believe the data recently presented from our WTX-124 and WTX-330 clinical programs displays the meaningful impact we can have on patients through our INDUKINE approach, and we are well positioned to advance both programs towards key inflection points in the coming quarters," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "We continue to focus on enrollment in these two clinical trials and look forward to providing additional clinical data updates as we look to address the unmet medical needs for cancer patients with late-stage disease."

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 pembrolizumab in multiple solid tumor types.
•In June 2024, at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Werewolf presented additional interim data from the monotherapy dose-escalation arm and preliminary dose-escalation data from the combination arm of its ongoing Phase 1/1b clinical trial of WTX-124. The updated data showcased that WTX-124 was clinically active and generally well-tolerated in patients, with highlights as follows as of the May 1, 2024, cutoff date:
◦WTX-124 as a monotherapy achieved three objective clinical responses, including one durable confirmed complete response and two partial responses in patients who were relapsed/refractory to immune checkpoint inhibitor therapy.
◦Responding patients had 100% regression of target lesions with responses occurring within the first two cycles of therapy and showing durability at the recommended dose for expansion (RDE).
◦Related treatment emergent adverse events were primarily mild to moderate in severity, manageable and reversible; no new safety signals were identified when WTX-124 was combined with pembrolizumab.
◦Analysis of paired tumor biopsies by NanoString suggests that WTX-124 robustly activated/expanded effector T cells preferentially over Tregs.
◦WTX-124 was clinically active and generally well tolerated in patients, not all of whom would be eligible for high dose IL-2 based on age, indication or other factors.

•Werewolf has selected 18 mg administered intravenously every two weeks (IV Q2W) as the monotherapy RDE to progress into the Phase 1b dose expansion portion of the trial based on clinical activity and acceptable safety in the outpatient setting.
•Werewolf disclosed data that demonstrated that the combination of WTX-124 with pembrolizumab was generally well tolerated with biomarker activity supporting the potential for combination efficacy and clinical activity was observed in two melanoma patients at the 12 mg combination dose level.

•Dose escalation is ongoing for WTX-124 in combination with pembrolizumab, with updated data and opening of expansion arms anticipated in the second half of 2024.
WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in advanced or metastatic solid tumors.
•In June 2024, Werewolf announced initial safety and efficacy data from its ongoing Phase 1 clinical trial of WTX-330 in patients with advanced or metastatic solid tumors or Non-Hodgkin Lymphoma. The data demonstrated that administration of WTX-330 reached therapeutically relevant exposure levels of systemically delivered IL-12 prodrug, with highlights as follows as of the June 12, 2024, cutoff date:
▪Compared to previous IL-12 therapeutic strategies at 500 ng/kg, at the 0.024 mg/kg dose, WTX-330 demonstrated an approximately 23-fold higher systemic drug concentration of IL-12 prodrug delivered to patients in the outpatient setting, with low free IL-12 levels across all dose levels.
▪One patient with metastatic melanoma achieved an unconfirmed partial response when treated with 0.024 mg/kg WTX-330 IV Q2W. Two additional patients with microsatellite stable colorectal cancer were treated with 0.032 mg/kg WTX-330 IV Q2W and achieved Response Evaluation Criteria in Solid Tumors (RECIST) stable disease.
▪All patients exhibited mild to moderate treatment-related toxicities primarily associated with the first dose, with no Grade 4 or Grade 5 related adverse events. Two patients experienced reversible dose-limited toxicities at the 0.032 mg/kg dose level.
•Werewolf anticipates sharing additional results from the checkpoint inhibitor-resistant or -naïve relapsed or refractory advanced tumor patient expansion arms in the fourth quarter of 2024.
Preclinical Portfolio: includes development candidates WTX-712 and WTX-518, INDUKINE molecules targeting IL-21 and IL-18, respectively, for treatment of cancer and an INDUKINE molecule delivering IL-10 for treatment of Irritable Bowel Disease.
•During the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2024, Werewolf presented two posters detailing progress of WTX-518 and WTX-712 preclinical programs, which the Company is progressing through investigational new drug application-enabling studies:
◦WTX-518: Demonstrated in vitro activity unimpeded by IL-18BP and selectivity that delivers active binding protein resistant (BPR) IL-18 to the tumor microenvironment, eliciting complete tumor regression in an MC38 mouse tumor model.
◦WTX-712: Demonstrated antitumor activity and tumor regression in the MC38 mouse tumor model. IL-21 was observed to achieve superior anti-tumor efficacy compared to IL-2 therapy in mouse tumor models that are highly resistant to anti-PD-1/PD-L1 treatment.
•During the American Association of Immunologists Meeting in May 2024, Werewolf presented a poster for its conditionally active IL-10 INDUKINE molecules for the treatment of inflammatory bowel disease.
◦Novel INDUKINE Molecules: Data demonstrated application of the Company’s PREDATOR platform in immune-mediated disease, indicating that IL-10 INDUKINE molecules were peripherally inactive and conditionally active in target tissue thereby preventing intestinal histological damage and inhibiting inflammatory cytokine production in mouse models of colitis.
Financial Results for the Second Quarter of 2024:
•Cash position: As of June 30, 2024, cash and cash equivalents were $135.3 million, compared to $139.2 million as of March 31, 2024. The Company believes its existing cash and cash equivalents as of June 30, 2024, will be sufficient to fund operational expenses and capital expenditure requirements through at least the first quarter of 2026.
•Collaboration revenue: Collaboration revenue was $1.1 million for the second quarter of 2024, compared to $8.1 million for the same period in 2023. Collaboration revenue consists of revenue recognized from the Company’s collaboration agreement with Jazz Pharmaceuticals (Jazz) and includes fixed payments received from Jazz, plus costs incurred for research services to be reimbursed by Jazz. As of June 30, 2024, Werewolf substantially completed its performance obligations under the collaboration agreement, so all remaining deferred revenue related to the collaboration agreement has been recognized.
•Research and development expenses: Research and development expenses were $15.3 million for the second quarter of 2024, compared to $9.6 million for the same period in 2023. The increase in research and development expenses was primarily due to the Company’s development efforts for WTX-124 and WTX-330, which continue to progress through their respective clinical trials, resulting in higher clinical trial costs and higher manufacturing costs to support those trials.
•General and administrative expenses: General and administrative expenses were $4.8 million for the second quarter of 2024, compared to $4.6 million for the second quarter of 2023.
•Net loss: Net loss was $17.2 million for the second quarter of 2024, compared to $5.1 million for the same period in 2023.