On November 7, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company reported a poster presentation highlighting the potential of the Company’s human neoantigen T-cell receptor platform (hunTR) to expand its TCR Library (Press release, Alaunos Therapeutics, NOV 7, 2022, View Source [SID1234623283]). The data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting in Boston, Massachusetts from November 8-12, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to present data demonstrating the ability of our proprietary hunTR platform to rapidly identify and validate neoantigen-reactive TCRs," commented Drew Deniger, Ph.D., Vice President, Research & Development. "By leveraging hunTR, our aim is to efficiently expand our TCR-T Library Phase 1/2 program with new, proprietary TCRs. This will enable us to broaden the pool of eligible patients who could benefit from our non-viral TCR-T cell therapies. We look forward to expanding our application of hunTR for additional shared KRAS, TP53, and EGFR mutations and rapidly take novel TCR candidates from the lab through to clinical translation."

hunTR is a high-throughput screening process that uses state-of-the-art bioinformatics and next generation sequencing to interrogate and deconvolute thousands of single T cells simultaneously. In the study, Alaunos evaluated ~525,000 TCR+HLA+neoantigen combinations in nine patients across colorectal, endometrial and breast cancers. All patients screened had at least one detectable neoantigen-reactive TCR, including one shared KRAS-Q61H mutation and 21 personal mutations. Of these, 78% were restricted by HLA Class II while 22% were restricted by HLA Class I. A median reactive hit rate of 13% was achieved per patient with an average of three unique neoantigen specificities. In subsequent patients screened only for KRAS mutations, multiple patients had TCRs reactive to KRAS-G12V, further demonstrating the ability of hunTR to discover exclusively owned hotspot mutation-reactive TCRs that could be added to the clinical library. The Company plans to continue to expand the application of hunTR to screen for additional shared KRAS, TP53, and EGFR mutations to rapidly advance new TCR library candidates from the lab through to clinical translation. In addition, hunTR may be suitable for personalized TCR-T therapies, enabling mutation-targeted cell therapy for most solid tumor cancers.

On November 7, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the third quarter of 2022 (Press release, Y-mAbs Therapeutics, NOV 7, 2022, View Source [SID1234623282]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The third quarter marked significant progress for DANYELZA. We are thrilled to report record sales of $12.5 million, a 28% increase compared to the previous quarter. In addition, DANYELZA was approved in Israel and submitted for marketing authorization in Brazil, and we look forward to our partners’ continued efforts to expand DANYELZA," said Thomas Gad, President and Interim Chief Executive Officer. "While we are truly disappointed by the outcome of the recent ODAC meeting for omburtamab after working tirelessly to receive breakthrough designation and submit the BLA to the FDA, we remain steadfast in our commitment to patients and caregivers who do not have access to an approved treatment, where there is a clear unmet need. However, while we await FDA’s formal decision on the BLA, we remain confident knowing that that Y-mAbs has never been defined by a single program or technology. Our expertise spans multiple verticals and disciplines, and we continue to invest confidently in our future with the promise of SADA while looking to maximize DANYELZA as the cornerstone of a sustainable pediatric oncology franchise funded by a strong balance sheet with $114.5 million in cash that is sufficient to support our business operations as currently planned into mid-2024."

Third Quarter 2022 and Recent Corporate Developments

On October 28, Y-mAbs announced the outcome of the FDA Oncologic Drugs Advisory Committee meeting, where the committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival
On October 3, Y-mAbs announced pivotal data from Study 101 for omburtamab in CNS/LM metastasis from neuroblastoma at the International Society of Pediatric Oncology (SIOP) annual congress
On September 26, Y-mAbs announced a regulatory filing for DANYELZA for the treatment of neuroblastoma in Brazil by Adium Pharma
On August 30, Y-mAbs announced that Takeda received marketing authorization for DANYELZA for the treatment of neuroblastoma in Israel
On July 12, Y-mAbs announced clearance of the IND for GD2-SADA
Financial Results

Revenues

Y-mAbs reported net revenues of $12.5 million and $33.8 million for the third quarter 2022 and nine months ended September 30, 2022, which represented increases of 40% and 34%, respectively, over $9.0 million and $25.3 million in the comparable periods of 2021. Net revenues in the nine months ended September 30, 2022 included $1.0 million of license revenue, compared to $2.0 million of license revenue in the corresponding period in 2021.

DANYELZA product revenue for the third quarter 2022 and nine months ended September 30, 2022, was $12.5 million and $32.8 million, respectively, which represented increases of 40% and 41%, respectively, over the corresponding periods in 2021 and an increase of 28% compared to the second quarter of 2022 DANYELZA product revenues of $9.8 million. The increase was primarily driven by an increase in the number of new U.S. patients in treatment during the third quarter of 2022.

As of September 30, 2022, Y-mAbs has delivered DANYELZA to 43 centers across the United States, corresponding to an increase of more than 19% in the number of centers since the end of the second quarter of 2022. During the third quarter of 2022, approximately 40% of the vials sold in the United States were sold outside Memorial Sloan Kettering ("MSK"), a decrease from the prior quarter as a result of MSK’s growth of new patients outpacing the growth of new patients at institutions outside MSK.

Operating Expenses

Research and Development

Research and development expenses were $22.4 million for the three months ended September 30, 2022, compared to $23.1 million for the three months ended September 30, 2021. The $0.7 million decrease reflects decreased spending for clinical trials, partially offset by increased costs for outsourced manufacturing services. Having completed the resubmission of the BLA for omburtamab in the first quarter of 2022, we are focusing on pipeline development programs for potential DANYELZA label expansion and advancing SADA constructs into the clinic.

Research and development expenses increased by $7.3 million to $71.8 million during the nine months ended September 30, 2022, compared to the prior year period. The $7.3 million increase mainly reflects an increase in outsourced manufacturing services and increased personnel costs dedicated to our advancement of DANYELZA, omburtamab, and the SADA constructs.

Selling, General, and Administration

Selling, general, and administrative expenses decreased by $0.4 million to $13.6 million for the three months ended September 30, 2022, compared to $14.0 million for the three months ended September 30, 2021. The decrease in selling, general and administrative expenses was primarily the result of a $2.1 million decrease in salary and stock-based compensation expense, partially offset by increased costs related to the commercialization of DANYELZA.

Selling, general, and administrative expenses increased by $10.7 million to $50.1 million for the nine months ended September 30, 2022, compared to $39.4 million for the nine months ended September 30, 2021. The increase in selling, general, and administrative expenses was primarily attributable to an $8.9 million increase in severance and share-based compensation expense related to our former chief executive officer in the nine months ended September 30, 2022, and to a lesser extent, the commercialization of DANYELZA.

Net Loss

We reported a net loss for the quarter ended September 30, 2022 of $27.5 million, or $0.63 per basic and diluted share, compared to a net loss of $28.9 million, or $0.66 per basic and diluted share for the quarter ended September 30, 2021. The decrease in net loss was primarily driven by the positive gross profit impact from increased revenues.

We reported a net loss for the nine months ended September 30, 2022 of $96.7 million, or $2.21 per basic and diluted share, compared to a net loss of $18.4 million, or $0.43 per basic and diluted share, for the nine months ended September 30, 2021. Net loss in the nine months ended September 30, 2021 included a $62.0 million net gain from the sale of our DANYELZA Priority Review Voucher, after sharing 40% of the net proceeds from the sale with MSK, pursuant to the terms of our license agreement with MSK. The increase in net loss in the nine months ended September 30, 2022 also reflects the impact of contractual severance-related benefits for our former chief executive officer, and increased research and development expenses, both as noted above, partially offset by the gross profit impact of DANYELZA’s revenue growth.

Cash and Cash Equivalents

We had approximately $114.5 million in cash and cash equivalents as of September 30, 2022, and we continue to expect a full-year 2022 cash burn of $78-83 million. Our cash and cash equivalents balance, when combined with anticipated DANYELZA revenues, is expected to be sufficient to fund our operations as currently planned into mid-2024. This estimate is based on our current business plan, and we have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.

This estimate does not include any potential product revenues for omburtamab, if approved, or any potential net proceeds from the potential receipt and sale of any priority review voucher, which we expect would be awarded to us if we receive approval of omburtamab. The estimate assumes receipt of a regulatory milestone payment for DANYELZA approval in China, but no new partnerships or other new business development-related sources of income.

Financial Guidance

Management reiterates all elements of its 2022 financial guidance including, anticipated:

DANYELZA product revenues of $45-$50 million;
Operating expenses of $162-167 million;
Total cash burn of $78-83 million; and
Cash position sufficient to fund current operations as planned into mid-2024.
The DANYELZA revenue guidance includes an incremental benefit from international revenues. We will review operating expenses based on final FDA feedback on the omburtamab BLA but expect no adverse impact on cash runway.

Webcast and Conference Call
Y-mAbs will host a conference call on Tuesday, November 8, 2022, at 4 p.m. Eastern Time. To participate in the call, please dial 877-300-8521 (domestic) or 412-317-6026 (international) and reference the conference ID 10172741.

A webcast will be available at: View Source;tp_key=92279e61e6

On November 7, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported an upcoming presentation outlining the unique molecular characteristics of WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting taking place November 8-12, 2022 in Boston, MA (Press release, Wugen, NOV 7, 2022, View Source [SID1234623281]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data highlight the advantageous anti-tumor profile of WU-NK-101 over conventional NK (cNK) cells. WU-NK-101 showed elevated expression of distinct cytokine-induced memory-like (CIML) NK markers, including cytotoxic molecules, activating receptors, and nutrient transporters. These features provide the mechanistic rationale for WU-NK-101’s enhanced anti-tumor activity and metabolic flexibility. Further, when deployed against solid tumor cancer cell lines, WU-NK-101 utilized monoclonal antibodies (mAbs) to robustly drive antibody-dependent cellular cytotoxicity (ADCC).

Data also demonstrate the utility of Wugen’s MonetaTM platform, a feeder cell-free system of fusion protein complexes to generate, expand, phenotypically maintain, and cryopreserve memory NK cells, such as WU-NK-101, while maintaining their potent anti-tumor CIML phenotype.

Together, these data support the clinical development of WU-NK-101 as an allogeneic memory NK cell therapy for the treatment of both liquid and solid tumors, both as monotherapy, and in combination with mAbs, solid tumor engagers, or other anti-tumor modalities.

The details of Wugen’s presentation at SITC (Free SITC Whitepaper) are as follows:

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

About the MonetaTM Platform

Wugen’s proprietary MonetaTM platform is a robust, scalable process to manufacture off-the-shelf memory natural killer (NK) cell therapies with enhanced anti-tumor functionality. The MonetaTM platform uses cytokine fusion complexes for streamlined and consistent manufacturing, is free of feeder cells for enhanced safety, and integrates cryopreservation to allow convenient dosing options for cancer patients.

On November 7, 2022 Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the third quarter ended September 30, 2022 (Press release, Verrica Pharmaceuticals, NOV 7, 2022, View Source [SID1234623280]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This quarter, we achieved significant progress in the transfer of our bulk material production to Piramal Pharma Solutions, and we are on track to resubmit our NDA for VP-102 for the treatment of molluscum contagiosum in the first quarter of 2023," said Ted White, Verrica’s President and Chief Executive Officer. "We greatly appreciate the collaborative effort from the entire Piramal team, as well as their commitment to completing this technology transfer on an expedited basis. We continue to look forward to providing physicians and caregivers the potential first FDA-approved treatment option for molluscum, a disease impacting an estimated six million patients annually in the United States."

Business Highlights and Recent Developments

VP-102

In July 2022, Torii Pharmaceutical Co., Ltd. ("Torii") dosed the first patient in its Phase 3 trial of VP-102 (referred to as TO-208 in Japan) for molluscum contagiosum in Japan, triggering an $8 million milestone payment from Torii to Verrica.
VP-LTX-315

Verrica continued to progress its Phase 2 clinical trial of VP-LTX-315, a potentially first-in-class oncolytic peptide immunotherapy, for the treatment of basal cell carcinoma. The Phase 2 trial is a three-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of VP-LTX-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. Part 1 (safety and dose escalation) is expected to conclude in Q1 2023.
Financial Results

Third Quarter 2022 Financial Results

Verrica recognized license revenues of $8.3 million for the three months ended September 30, 2022 and no license revenue for the same period in 2021 related to the Collaboration and License Agreement (the "Torii Agreement") with Torii for supplies and development activity with Torii.
Research and development expenses were $2.9 million in the third quarter of 2022, compared to $3.8 million for the same period in 2021. The decrease was primarily attributable to a reduction of Chemistry, Manufacturing and Controls (CMC) and clinical costs related to our development of VP-102 for molluscum contagiosum, external genital warts and common warts and reduction in compensation due to reduction in headcount.
General and administrative expenses were $3.9 million in the third quarter of 2022, compared to $8.0 million for the same period in 2021. The decrease was primarily a result of higher expenses in the prior year related to pre-commercial activities for VP-102 and reduction in compensation costs due to reduction in headcount.
For the third quarter of 2022, net income on a GAAP basis was $83 thousand, or $0.00 per share (basic and diluted), compared to a net loss of $12.8 million, or $0.47 per share, for the same period in 2021.
For the third quarter of 2022, non-GAAP net income was $2.9 million, or $0.07 per share (basic and diluted), compared to a non-GAAP net loss of $11.0 million, or $0.40 per share, for the same period in 2021.
Year-to-Date September 2022 Financial Results

Verrica recognized license revenues related to the Torii Agreement of $9.0 million for the nine months ended September 30, 2022 compared to $12.0 million for the same period in 2021. The current period license revenue was related to an $8.0 million milestone payment and $1.0 million related to Torii’s purchase of supplies and reimbursement for development activities. License revenue for the nine months ended September 30, 2021 comprised of $0.5 million received in December 2020, and an $11.5 million up-front payment paid in April 2021, pursuant to the exercise of the license option on March 17, 2021 per the Torii Agreement.
Research and development expenses were $9.8 million for the nine months ended September 30, 2022, compared to $12.6 million for the same period in 2021. The decrease was primarily attributable to one-time payments of $2.3 million and $1.0 million to Lytix upon the achievement of regulatory milestones for LTX-315, during the nine months ended September 30, 2021 and 2022, respectively, as well as decreased CMC and clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum, external genital warts, and common warts in 2021.
General and administrative expenses were $14.2 million for the nine months ended September 30, 2022, compared to $21.9 million for the same period in 2021. The decrease was primarily a result of a decrease in expenses related to pre-commercial activities for VP-102 and reduction in compensation costs due to reduction in headcount.
For nine months ended September 30, 2022, net loss on a GAAP basis was $18.6 million, or $0.58 per share, compared to a net loss of $25.5 million, or $0.95 per share, for the same period in 2021.
For nine months ended September 30, 2022, non-GAAP net loss was $12.7 million, or $0.40 per share, compared to a non-GAAP net loss of $19.8 million, or $0.73 per share, for the same period in 2021.
As of September 30, 2022, Verrica had aggregate cash, cash equivalents, marketable securities and restricted cash of $39.5 million. The Company believes that its existing cash, cash equivalents and marketable securities as of September 30, 2022, will be sufficient to support planned operations into the third quarter of 2023.
Non-GAAP Financial Measures

In evaluating the operating performance of its business, Verrica’s management considers non-GAAP income (loss) from operations, non-GAAP net income (loss) and non-GAAP net income (loss) per share. These non-GAAP financial measures exclude stock-based compensation charges, non-cash interest expense and loss on debt extinguishment that are required by GAAP. Verrica believes that non-GAAP income (loss) from operations, non-GAAP net income (loss) and non-GAAP net income (loss) per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. Non-GAAP income (loss) from operations, non-GAAP net income (loss) and non-GAAP net income (loss) per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP income (loss) from operations, non-GAAP net income (loss) and non-GAAP net income (loss) per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.

About VP-102

Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Upon submission of the NDA for VP-102, Verrica intends to seek approval to market VP-102 in the United States under the brand name YCANTH. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

About Molluscum Contagiosum (Molluscum)

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

On November 7, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Monday, November 14, 2022 to report its third quarter 2022 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, NOV 7, 2022, View Source [SID1234623279]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the live conference call, please register using the conference link here. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. A webcast of the call will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.