On November 14, 2023 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), reported financial results for the third quarter ended September 30, 2023 (Press release, Alaunos Therapeutics, NOV 14, 2023, View Source [SID1234637648]). As previously announced, the Company is exploring strategic alternatives with Cantor Fitzgerald & Co. as its strategic advisor. Alaunos continues to reduce spend and cost-savings measures taken to date are expected to extend its cash runway into the second quarter of 2024.

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Operational & Corporate Update

Clinical Data from TCR-T Library Phase 1/2 Trial: Eight patients were treated and evaluated in the Company’s TCR-T Library Phase 1/2 Trial. Patients with pancreatic (3), colorectal (4) and non-small cell lung cancer (1) were treated, with certain of the pancreatic and colorectal patients also having lung metastases. Overall, the trial showed the Company’s T cells were well-tolerated in all evaluable participants with no dose-limiting toxicities (DLTs) and no immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. All cytokine release syndrome (CRS) events were within grades 1-3 and were self-limiting or resolved with standard clinical management and, in some cases, a single dose of tocilizumab.

One patient with non-small cell lung cancer (NSCLC) achieved an objective partial response with six months progression-free survival. Six other patients achieved best overall response of stable disease. The total overall response rate was 13% and disease control rate was 87% in evaluable patients with advanced, metastatic, refractory solid tumors (see attached figure). Disease control was measured by objective responses and stable disease. Increased secretion of interferon-gamma relative to baseline was detected in all patients’ serum post-cell transfer suggesting recognition of the tumor by the infused TCR-T cells. Persistence of TCR-T cells in peripheral blood was detected in all evaluable patients at their last follow-up, including up to six months in one patient. Infiltration of TCR-T cells into the tumor was also detected in three samples where a fresh biopsy was collected suggesting homing to the tumor microenvironment. All patients have progressed or withdrawn from the trial and long-term follow-up is ongoing for a subset of patients with no further intervention per the treatment protocol. This trial established proof-of-concept that Sleeping Beauty TCR-T cells can result in objective clinical responses and recognize established tumors in vivo.

Despite the encouraging TCR-T Library Phase 1/2 Trial data, based on the substantial cost to continue development and the current financing environment, Alaunos announced in August 2023 that it would not pursue any further development of its clinical programs.

hunTR TCR Discovery Platform Identifies Proprietary TCRs: Alaunos has discovered multiple proprietary TCRs targeting driver mutations through its hunTR TCR discovery platform. In addition to TCRs that recognize KRAS and TP53 mutations similar to those licensed from the National Cancer Institute, the Company identified additional TCRs that bind to other driver mutations and TCRs that are restricted to additional HLAs. Alaunos believes that the hunTR library has the potential to allow for the treatment of a large patient population.

Strategic Alternatives: The Company continues to explore strategic alternatives, which may include but are not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. In connection with the strategic reprioritization, the Company has reduced its workforce by approximately 80% to date in order to streamline the organization and to maximize its cash runway.

Third Quarter Ended September 30, 2023, Financial Results

Collaboration Revenue: Collaboration revenue was $0 for the third quarter of 2023, compared to $2.9 million for the third quarter of 2022. The decrease was due to revenue earned under the Solasia License and Collaboration Agreement in 2022 that did not recur in 2023.

Research and Development Expenses: Research and development expenses were $3.7 million for the third quarter of 2023, compared to $7.9 million for the third quarter of 2022, a decrease of approximately 54%. The decrease was primarily due to lower program expenses of $0.8 million as a result of our wind-down of clinical activities, a $0.6 million decrease in employee-related expenses due to our reduced headcount, an accrual adjustment related to our de-prioritized clinical programs of $0.3 million and a $2.5 million milestone payment to MD Anderson in 2022 under the terms of our patent and technology license agreement that did not recur in 2023.

General and Administrative Expenses: General and administrative expenses were $3.6 million for the third quarter of 2023, compared to $3.3 million for the third quarter of 2022, an increase of approximately 9%. The increase was primarily due to higher consulting and professional services expenses of $0.9 million related to increased legal costs, partially offset by a $0.4 million decrease in employee-related expenses due to our reduced headcount and a $0.2 million decrease in insurance fees.

Restructuring Costs: Restructuring costs were $0.4 million for the third quarter of 2023, compared to $0 for the third quarter of 2022 due to severance expenses for terminated employees related to our strategic reprioritization announced in August 2023.

Property and Equipment and Right-of-Use Asset Impairment: Property and equipment and right-of-use asset impairment charges were $1.0 million for the third quarter of 2023, compared to $0 for the third quarter of 2022 due to changes in the intended use of our property and equipment and lease right-of-use asset following the announcement of our strategic reprioritization in August 2023.

Net Loss: Net loss was $8.5 million, or $(0.04) per share, for the third quarter of 2023, compared to a net loss of $8.9 million, or $(0.04) per share, for the third quarter in 2022.

Cash, Cash Equivalents and Restricted Cash: As of September 30, 2023, Alaunos had approximately $11.9 million in cash balances. The Company expects to have sufficient cash resources to fund operations into the second quarter of 2024 as a result of its ongoing strategic reprioritization.

On November 14, 2023 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the third quarter ended September 30, 2023 (Press release, VolitionRX, NOV 14, 2023, View Source [SID1234637647]). Volition management will host a conference call tomorrow, November 15 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

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Cameron Reynolds, President and Group Chief Executive Officer at Volition, commented:

"I am pleased to report that in the first nine months of 2023 revenue for the Nu.Q Vet Cancer Test grew almost five-fold over the prior year period, reflecting sales of the reference kits through our global, regional and local supply agreements. Additionally, total year-to-date revenue was $531,000, a 185% increase compared to the comparable period of 2022. We believe that these results demonstrate steady growth, but not yet the "ramp" in revenues that we anticipate. We expect revenues to accelerate as we close out 2023 and into the early part of 2024 as several additional distributors come online with our Nu.Q Vet Test.

"We continued to make considerable progress with our Nu.Q NETs pillar. Most recently, we completed the Q-Sub process with the U.S. Food and Drug Administration, and we are happy to announce that they have agreed to the regulatory pathway of a traditional 510(k) with an adjudicated clinical comparator. We are grateful for the opportunity to participate in the Q-Sub process and appreciate the feedback we have received. The interactions were engaging and helpful and we feel gave us a clear regulatory path we need to follow for this potentially exciting opportunity.

"We hosted our first Key Opinion Leader Roundtable Event focused on sepsis in September and published an expert-led report. We also presented new data at the ESICM congress in Milan in October and were featured in a peer-reviewed publication from one of our Centers of Excellence in Europe.

"In October, we unveiled what we believe to be an entirely new cancer detection method at ESMO (Free ESMO Whitepaper) 2023, the annual congress of the European Society for Medical Oncology, and hosted a webinar detailing this transformational method. The results to date are exciting and we are now developing a range of cancer-specific assays which we expect to be more accurate than these preliminary results, and look forward to sharing our progress beginning in the first quarter of 2024. We believe that this opportunity is significant, and we have been encouraged by the level of interest shown by a range of leading diagnostic and liquid biopsy companies following ESMO (Free ESMO Whitepaper).

"I am also delighted in the progress we are making to ensure our Nu.Q Vet Cancer Test is accessible worldwide, with our recent launch in the UK and Ireland through two leading local companies; NationWide Laboratories and Veterinary Pathology Group. We anticipate launches in additional markets in Asia in the coming months."

An interview with Cameron Reynolds, President and Group Chief Executive Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Terig Hughes, Group Chief Financial Officer of Volition.

View Source

Financial Highlights

·

Cash and cash equivalents as of September 30, 2023, totaled approximately $10.8 million compared with $10.9 million at the end of 2022.
·

Subsequent to quarter end, a Walloon institutional fund and regional government bodies of the Walloon Region of Belgium approved providing additional funding to the company aggregating approximately $6 million. We expect the funding transactions to close this month.
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Expect to receive a further $13 million in milestone payments from Heska Corporation in the coming months.

Event: VolitionRx Limited Third Quarter 2023 Earnings and Business Update Conference Call

Date: Wednesday, November 15, 2023

Time: 8:30 a.m. U.S. Eastern Time

U.S. & Canada Dial-in: 1-877-407-9716 (toll free)

U.K. Dial-in: 0 800 756 3429 (toll free)

Toll/International: 1-201-493-6779

Conference ID: 13742634

Cameron Reynolds, President and Group Chief Executive Officer of Volition, will host the call along with Terig Hughes, Group Chief Financial Officer, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, Dr. Andrew Retter, Medical Consultant to Volition and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on important events which have taken place in the third quarter of 2023 and upcoming milestones.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until November 29, 2023. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13742634.

On November 14, 2023 Vincerx Pharma, Inc. (Nasdaq: VINC)("Vincerx"), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the third quarter ended September 30, 2023 and provided a corporate update (Press release, Vincerx Pharma, NOV 14, 2023, View Source [SID1234637646]).

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"This has been a standout quarter for Vincerx, with progress across all three clinical programs, including VIP943, our first ADC from the VersAptx Platform, our versatile and adaptable, next-generation bioconjugation platform, and VIP236, our first-in-class SMDC," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "The Vincerx team has done an outstanding job delivering ahead of expectations. Not only were we able to dose our first VIP943 patient within a matter of weeks of FDA clearance, but we have quickly moved through our first cohort and are beginning enrollment in our second cohort. This momentum is a testament to the promising safety profile seen in the first cohort and the enthusiasm from investigators participating in the trial. We expect to report preliminary data from this study in mid-2024."

"We also continued to make excellent progress with our other clinical programs. VIP236, our first-in-class SMDC for advanced solid tumors, is dosing patients under an optimized dosing schedule of once every three weeks, and we are pleased with the early safety profile we are seeing. We expect to report preliminary data in early 2024. In addition, enitociclib, our CDK9 inhibitor, continues to show promise. The transformed follicular lymphoma patient in our monotherapy study remains on treatment and has achieved long-term stable disease for more than 16 months with a 51% reduction in target lesions. Furthermore, our collaboration with the National Institute of Health (NIH) on a Phase 1 dose-escalation study of enitociclib with venetoclax and prednisone continues to make progress, with four patients dosed and an overall favorable safety profile. Even more exciting, the first patient on the second dose level remains on study with a partial response with evidence of an 80% reduction in the pulmonary lesion and resolution of skin lesions from their peripheral T-cell lymphoma," added Dr. Hamdy.

"We continue to take a very disciplined approach to our portfolio, focusing our resources on our two lead programs, VIP943 and VIP236. Concurrently, we are exploring business development opportunities that can advance all of our clinical programs as well as leverage the power of our VersAptx Platform. The therapeutic and safety potential of ADCs and other conjugates is being widely recognized, as evidenced by the overall excitement and activity in the ADC space, including collaborations, acquisitions, and positive clinical results. We believe that our next-generation ADC technology represents a significant step forward in the treatment of cancer by potentially overcoming the safety and efficacy challenges associated with many ADCs. As a result, we feel we are well-positioned to capitalize on industry enthusiasm for bioconjugates," concluded Dr. Hamdy.

Third Quarter 2023 Corporate Highlights:

VIP943: CD123-KSPi ADC for leukemias and myelodysplastic syndrome

VIP943, the first ADC from our 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 our CellTrapper technology. Our proprietary effector chemistry (linker + payload) was designed to reduce non-specific release of the payload and ensure payload accumulation in cancer cells versus healthy cells. The increased therapeutic index has the potential to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities.

•
VIP943 is in a Phase 1 dose-escalation trial evaluating patients with relapsed/refractory acute myeloid leukemia, myelodysplastic syndrome, and B-cell acute lymphoblastic leukemia who have exhausted standard therapeutic options (NCT06034275).

•
The VIP943 IND was approved by the FDA within 30 days, and we dosed our first patient in less than three weeks of FDA clearance. In addition, enrollment has moved quickly (Cohort 1, n=3), and we are now enrolling our second cohort. We are pleased with the early safety profile.

•
We will present new data on robust preclinical activity at the 65th American Society for Hematology Meeting (ASH 2023) in December.

•
We expect to report preliminary clinical trial data in mid-2024.

VIP236: SMDC with αvb3 integrin binder linked to optimized CPT payload for solid tumors

•
VIP236, the first-in-class SMDC from our VersAptx Platform, consists of an αvb3 integrin binder, a neutrophil elastase linker cleaved in the tumor microenvironment, and a camptothecin (CPT) payload optimized for high permeability and low efflux. VIP236 was designed to deliver its payload to advanced/metastatic tumors that express αvb3.

•
Preclinical data show enhanced efficacy, independent of HER2 status, in patient-derived and cell line-derived gastric cancer models compared with ENHERTU, an approved ADC.

•
VIP236 is being evaluated in a Phase 1 dose-escalation trial treating patients with advanced or metastatic solid tumors (NTC05371054). As VIP236 is a first-in-class drug, the Phase 1 trial is evaluating various dosing schedules.

•
To date, 10 patients with advanced or metastatic disease that has relapsed or is refractory to standard of care have received VIP236; the early safety profile of once every three weeks dosing is promising.

•
We expect to report preliminary clinical trial data in early 2024.

VIP924: CXCR5-KSPi ADC for B-cell malignancies

•
VIP924, the second ADC from our VersAptx Platform, consists of an anti-CXCR5 antibody, a unique linker cleaved intracellularly by legumain, and a novel KSPi payload enhanced with our CellTrapper technology. Our proprietary effector chemistry (linker + payload) was designed to reduce non-specific release of the payload and ensure payload accumulation in cancer cells versus healthy cells. The increased therapeutic index has the potential to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities.

•
VIP924 preclinical data demonstrate significant tumor growth inhibition in a panel of lymphoma cell lines and cell line- and PDX-derived lymphoma models. VIP924 also induces sustained tumor regression in mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL) models, including ibrutinib-refractory MCL models.

LOGO

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At ASH (Free ASH Whitepaper) 2023, preclinical data will be presented showing that our first-in-class anti-CXCR5 ADC compares favorably to the approved ADCs, Polivy and Zynlonta.

•
Despite compelling preclinical data, we continue to judiciously pace our investment in VIP924 to focus resources on VIP236 and VIP943.

Enitociclib: CDK9 inhibitor for hematologic malignancies and solid tumors

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Enitociclib, a highly selective CDK9 inhibitor, prevents activation of RNA polymerase II, resulting in reduction of known oncogenes MYC and MCL1.

•
Enitociclib is in a dose-escalation Phase 1 trial (NTC05371054) in collaboration with the NIH evaluating the combination of enitociclib, venetoclax and prednisone in DLBCL and peripheral T-cell lymphoma (PTCL). The first dose level completed enrollment with no drug-related safety signal (n=3; 1=DLBCL, 2=PTCL). The first patient on the second dose level (n=1; 1=PTCL) remains on study with a partial response due to an 80% reduction in the pulmonary lesion on computerized tomography (CT) scan and resolved skin lesions. Investigators are pleased with the safety profile of this novel combination and continue with enrollment.

•
Additional combination studies will be determined based on financing/partnering support.

•
Proof-of-concept monotherapy efficacy has been generated in early-stage clinical studies:

•
Hematologic malignancies: two patients with double-hit DLBCL achieved complete metabolic responses after 10 cycles of treatment and remain in remission, off treatment, for over four years; one patient with transformed follicular lymphoma remains on treatment, achieving long-term stable disease for over 16 months with a 51% reduction in target lesions.

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Solid tumors: 13 responses of stable disease, including durable disease control, in patients with ovarian, pancreatic, and salivary gland cancer.

•
Strong preclinical evidence for additional indications (eg, multiple myeloma) and pediatric indications.

•
Collaborators from the University of Calgary will present a poster at ASH (Free ASH Whitepaper) 2023 showing preclinical activity in pediatric leukemia.

Additional Corporate Highlights

•
Our next-generation bioconjugation platform is now known as the VersAptx Platform. This name reflects the versatile and adaptable features and strengths of this innovative technology.

•
We received a one-year extension of Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency’s (EMA) Micro, Small and Medium-Sized Enterprise, enabling us to become eligible for EMA fee reductions and waiver and other financial incentives.

Third Quarter 2023 Financial Results

•
Vincerx had approximately $20.8 million in cash, cash equivalents and marketable securities as of September 30, 2023, as compared to approximately $52.5 million as of December 31, 2022. Based on its current business plans and assumptions, Vincerx believes its available capital will be sufficient to meet its planned operating requirements into late 2024.

•
Research and development expenses for the three- and nine-months ended September 30, 2023 were approximately $6.8 million and $25.3 million, as compared to approximately $11.1 million and $40.8 million for the same periods in 2022. The decrease for the three months ended September 30, 2023 compared with the same period in 2022 is primarily the result of decreases in manufacturing services associated with our ADC program of approximately $4.1 million and clinical services of approximately $0.9 million, partially offset by the $1.0 million development milestone in connection with Vincerx’s IND filing for VIP943. The decrease for the nine months ended September 30, 2023 compared with the same period in 2022 is primarily the result of decreases in manufacturing services associated with our ADC program of approximately $5.5 million, stock-based compensation expense of approximately $5.1 million, clinical services of approximately $2.7 million, and payroll related costs of approximately $1.7 million as a result of our headcount reduction in June 2022.

•
General and administrative expenses for the three- and nine-months ended September 30, 2023 were approximately $3.5 million and $11.8 million, as compared to approximately $4.5 million and $14.9 million for the same periods in 2022. These decreases are primarily due to decreases in stock-based compensation expense of approximately $0.5 million and $2.3 million for the three- and nine-months ended September 30, 2023, respectively, as well as a decrease in professional services of $0.5 million and $0.8 million for the three and nine months ended September 30, 2023, respectively.

•
For the quarter ended September 30, 2023, Vincerx reported a net loss of approximately $9.7 million, or $0.46 per share, compared to a net loss of approximately $16.9 million, or $0.80 per share, for the quarter ended September 30, 2022.

On November 14, 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 announced financial results for the third quarter ended September 30, 2023 (Press release, Werewolf Therapeutics, NOV 14, 2023, View Source [SID1234637644]).

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"Werewolf has made tremendous strides since last quarter, most notably with the presentation of promising first-in-human data from our lead clinical program, WTX-124. Preliminary data presented at SITC (Free SITC Whitepaper) indicate that WTX-124 is well-tolerated and elicits monotherapy biomarker and clinical activity, including two patients with ongoing unconfirmed partial responses in the 12 mg cohort," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "We look forward to sharing additional data to inform our recommended dose to proceed into monotherapy expansion arms in the first half of 2024. We are also pleased to announce the addition of WTX-518, an IL-18 INDUKINE molecule, as our newest pipeline candidate and expect to present preclinical data on this molecule in the first half of 2024."

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.

•In November 2023, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting, Werewolf presented preliminary clinical data from the first four monotherapy dose escalation cohorts of Study WTX-124×2101, its Phase 1/1b, multi-center, open-label clinical trial evaluating WTX-124 in patients with immunotherapy sensitive advanced or metastatic solid tumors who have failed standard of care treatment, including checkpoint inhibitor therapy. The preliminary data established proof of mechanism for WTX-124 and proof of concept for Werewolf’s INDUKINE design, with highlights as follows, as of the data cut-off date of October 18, 2023:

◦WTX-124 was generally well-tolerated across 16 patients, with no Grade 3 or higher treatment-related adverse events, no related serious adverse events and no evidence of vascular leak syndrome, at doses up to and including 12 mg.
◦Early evidence of antitumor activity was observed in monotherapy dose escalation cohorts 3 (6 mg) and 4 (12 mg), including two patients with ongoing unconfirmed partial responses (PR) dosed at 12 mg. An additional patient dosed at 12 mg showed evidence of anti-tumor activity.
◦These WTX-124 data are consistent with key INDUKINE pharmaceutical properties, including systemic delivery of the WTX-124 prodrug with preferential activation in the tumor microenvironment while preserving a wide therapeutic index supportive of continued dose escalation.
•Werewolf is progressing Study WTX-124×2101, and dose escalation is ongoing in both the monotherapy and combination therapy arms of the study. The Company expects to report additional interim data from monotherapy dose escalation cohorts, declaration of a recommended dose for expansion, and opening of the monotherapy expansion arms in the first half of 2024.
•In September 2023, Werewolf hosted a virtual event reviewing the IL-2 landscape and opportunity for WTX-124 among next-generation therapeutic approaches. The event featured key opinion leader in cytokines and cancer immunotherapy, Michael Atkins, M.D., William M. Scholl Professor and Vice Chair of the Department of Oncology at Georgetown University.

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.

Additional Updates:
•Werewolf is announcing the addition of WTX-518 as a pipeline candidate for preclinical development. WTX-518 is a conditionally activated IL-18 INDUKINE molecule in development for the treatment of cancer and is wholly owned by Werewolf. IL-18 is designed to promote activation of immune cells in the tumor microenvironment resulting in antitumor immunity. Werewolf expects to present preclinical data regarding this molecule in the first half of 2024.
•At SITC (Free SITC Whitepaper), Werewolf also presented five posters with preclinical and translational data supporting PREDATOR platform capabilities; pipeline programs, including both clinical candidates as well as WTX-712 (IL-21); and the potential of INDUKINE molecules as a complement to other anti-cancer approaches, such as checkpoint inhibitors and cell therapy. All posters are available at investors.werewolftx.com/news-and-events/scientific-resources.

Financial Results for the Third Quarter of 2023:
•Cash position: As of September 30, 2023, cash and cash equivalents were $130.1 million, compared to $137.5 million as of June 30, 2023. The Company also had restricted cash and cash equivalents of $21.2 million as of September 30, 2023 and June 30, 2023, respectively. The Company expects that its existing cash and cash equivalents 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 $5.9 million for the third quarter of 2023, compared to $5.0 million for the same period in 2022. Collaboration revenue consists of revenue recognized from the Company’s licensing agreement with Jazz Pharmaceuticals (Jazz) and includes fixed payments received from Jazz, plus costs incurred for research services to be reimbursed by Jazz.
•Research and development expenses: Research and development expenses were $10.8 million for the third quarter of 2023, compared to $13.1 million for the same period in 2022. The decrease in research and development expenses was primarily due to a decrease in contract manufacturing costs associated with WTX-124 and WTX-330. The decline in contract manufacturing costs was partially offset by an increase in clinical trial costs for WTX-124 and WTX-330.
•General and administrative expenses: General and administrative expenses were $4.3 million for the third quarter of 2023, compared to $4.4 million for the same period in 2022. The decrease in general and administrative expenses was primarily due to a reduction in insurance premiums, which was offset in part by an increase in costs incurred to protect the Company’s intellectual property.
•Net loss: Net loss was $8.3 million for the third quarter of 2023, compared to $11.9 million for the same period in 2022.

On November 14, 2023 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported a business update and announced financial results for the quarter ended September 30, 2023 (Press release, VBI Vaccines, NOV 14, 2023, View Source [SID1234637643]).

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"In Q3, we were focused on pipeline execution with continued revenue growth for PreHevbrio, meaningful data readouts and clinical advancements of our lead development candidates, and the announcement of a next-generation proprietary technology that blends the benefits of our eVLP technology with those of mRNA platforms," said Jeff Baxter, VBI’s President and CEO. "Additionally, in this period of challenging financial markets for biotechnology companies, we are intensely focused on managing our operating expenses and capital to fuel sustainable growth and value for key stakeholders."

Recent Key Program Achievements and Projected Upcoming Milestones

Hepatitis B (HBV)

PreHevbrio [Hepatitis B Vaccine (Recombinant)]

Global net product sales increased 52% from Q2 2023 with $1.1 million earned in Q3 2023
Net product sales are net of the provision for discounts, chargebacks, rebates, and fees – in the aggregate, these discounts reduced sales by $0.6 million in Q3 2023, from $1.7 million gross sales to $1.1 million net sales
Quarter-over-quarter momentum continues to grow, with more than a 10% increase in total customer base in Q3 as compared to Q2 2023
Contracting network across multiple market segments also continues to see growth, including with retail partners, Integrated Delivery Networks (IDNs) and large hospital systems, multiple large military and federal facilities, prisons, and independent and public health clinics
July 2023: Exclusive licensing deal with Brii Biosciences (Brii Bio) announced for the development and commercialization of PreHevbri in the Asia Pacific region, excluding Japan
October 2023: Peer-reviewed publication of review of data from studies of PreHevbrio published in Expert Review of Vaccines
Manuscript title: "PreHevbrio: the first approved 3-antigen hepatitis B vaccine"
Q4 2023: New market launches expected in additional European Union countries through partnership with Valneva (under brand name PreHevbri)
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

July 2023: Announced exclusive global licensing agreement with Brii Bio for the development and commercialization of VBI-2601
This expanded partnership adds VBI-2601 to Brii Bio’s HBV portfolio, which, through a series of strategic investments and partnerships is among the most advanced in the chronic HBV field
VBI will continue to share in the success of VBI-2601, with the potential to receive regulatory and commercial milestone payments, in addition to potential double-digit royalties on global sales of VBI-2601
September 2023: Brii Bio announced topline interim results of Phase 2 study evaluating VBI-2601 in combination with pegylated interferon-alpha (PEG-IFNα) in chronic HBV patients
The combination treatment elicited improved hepatitis B S-antigen (HBsAg) loss and seroconversion vs. PEG-IFNα alone both at the end of treatment and after 12 weeks of follow up
November 2023: In two late-breaking poster presentations at AASLD The Liver Meeting 2023, Brii Bio announced new data from Phase 2 studies of VBI-2601 (BRII-179) highlighting progress towards achieving HBV functional cure:
Direct evidence that BRII-179-induced functional antibody responses can contribute to increased and sustained HBsAg loss rate
New insight utilizing BRII-179 to enrich patients with intrinsic humoral immune responses for higher HBsAg loss or HBV functional cure rates
Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

September 2023: Announcement of first patients dosed in the randomized, controlled Phase 2b study of VBI-1901, an FDA Fast Track and Orphan Drug Designated cancer vaccine candidate, in recurrent GBM patients
Around Year-End 2023: Expected initiation of VBI-1901 study arm, as part of Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial, in combination with Agenus Inc.’s anti-PD-1, balstilimab, in primary GBM patients
H2 2024: Interim data analyses from Phase 2b study in recurrent GBM patients expected, subject to speed of patient enrollment
COVID-19 & Coronaviruses

VBI-2901: Multivalent Pan-Coronavirus Vaccine Candidate

September 2023: Initial data from Phase 1 study of VBI-2901 reported – the first clinical data from a pan-coronavirus vaccine candidate
VBI-2901 demonstrated vaccine benefit – reflected as boosting of and/or greater durability of antibody titer maintenance:
All participants saw boosting and/or high neutralizing antibody responses against a panel of COVID-19 variants and two animal coronaviruses
Participants with lower baseline antibody titers, reflecting a higher-risk population, saw the greatest boosting effect (5-14x strain-dependent boosting)
Durability benefit observed regardless of baseline antibody levels, with only about 25% reduction in geometric mean titer (GMT) against the Wuhan strain after 5 months vs. peak responses – compared to an approximate 77% decline in GMT against the Wuhan strain vs. peak responses to a licensed mRNA vaccine [Gilboa M, 2022]1
Q1 2024: Additional durability and breadth data from the Phase 1 study expected
Funds from existing partners, including the Canadian government and the Coalition for Epidemic Preparedness Innovations (CEPI) are available to fund the next phase of clinical development
Novel mRNA-Launched eVLP (MLE) Technology Platform

October 2023: Development of a novel mRNA-launched eVLP (MLE) technology platform announced, supported by preclinical data that have demonstrated significant immunologic and manufacturing benefits
MLE technology enables the manufacture of particulate vaccines, capable of driving polyfunctional B-cell and T-cell activation, on accelerated timelines, similar to other mRNA vaccine production timelines
New platform has the potential to be leveraged across infectious disease, cancer, and allergic and autoimmune disease indications
Third Quarter 2023 Financial Results

Cash Position: VBI ended the third quarter of 2023 with $35.5 million in cash as compared with $62.6 million in cash as of December 31, 2022.
Revenues, net: Revenues, net for the third quarter of 2023 were $6.6 million as compared to $0.3 million for the same period in 2022. The revenue increase was a result of an increase in product sales of PreHevbrio in the U.S. and of PreHevbri to our partner, Valneva, in Europe, in addition to the license revenue and R&D services revenue associated with the HBV license agreement, expanded in July 2023, with Brii Bio.
Cost of Revenues: Cost of revenues was $2.5 million in the third quarter of 2023 as compared to $2.7 million in the third quarter of 2022. The decrease in the cost of revenues was due to increased product sales, offset by lower direct labor costs as a result of the recent organization changes that reduced our internal workforce.
Research and Development (R&D): R&D expenses for the third quarter of 2023 were $1.5 million as compared to $5.0 million for the third quarter of 2022. R&D expenses were offset by $2.7 million in the third quarter of 2023 and $2.4 million in the third quarter of 2022 due to government grants and funding arrangements.
Sales, General, and Administrative (SG&A): SG&A expenses for the third quarter of 2023 were $9.0 million as compared to $14.2 million for the same period in 2022. The decrease in SG&A expenses was mainly a result of the recent organizational changes that reduced our internal workforce, as announced in April 2023, the redefined deployment strategy of our U.S. commercial field force, and a reduction in activity-based commercial expenses related to PreHevbrio.
Net Cash Used in Operating Activities: Net cash used in operating activities for the nine months ended September 30, 2023, was $48.8 million compared to $54.6 million for the same period in 2022. The decrease in cash outflows is largely a result of non-cash reconciling items, mainly impairment charges and unrealized foreign exchange loss, and the change in operating working capital, most notably in inventory, other current assets, accounts payable, deferred revenues, and other current liabilities. As announced on April 4, 2023, VBI implemented cost saving measures that are expected to reduce operating expenses from normal business in the second half of 2023 by 30-35% compared to the second half of 2022.
Net Loss and Net Loss Per Share: Net loss and net loss per share for the third quarter of 2023 were $20.4 million and $1.01, respectively, compared to a net loss and net loss per share of $25.2 million and $2.93 for the third quarter of 2022, respectively.
Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss: Net loss, excluding impairment charges and foreign exchange loss, and net loss per share, excluding impairment charges and foreign exchange loss, for the third quarter of 2023 were $8.0 million and $0.38, respectively, compared to $22.5 million and $2.62 for the third quarter of 2022, respectively. See "Non-GAAP Financial Information" below for additional information regarding this non-GAAP financial measure, and "GAAP to Non-GAAP Reconciliation" for a reconciliation of this non-GAAP financial measure to net loss and net loss per share.
Impairment charges and foreign exchange loss for the third quarter of 2023 were $3.6 million and $8.8 million, respectively, as compared to none and $2.7 million for the third quarter of 2022. Certain intercompany loans between the Company and its subsidiaries are denominated in a currency other than the functional currency of each entity. The primary driver of the increase in foreign exchange loss was the impact of the relative strengthening of the U.S. and Canadian Dollars against the New Israeli Shekel upon translation of these intercompany loans.