On August 8, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported financial results for the second quarter ending June 30, 2022 and provided a corporate update (Press release, VBI Vaccines, AUG 8, 2022, View Source [SID1234617800]).

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Jeff Baxter, VBI’s President and CEO commented:

"Since the U.S. launch of PreHevbrio, our field teams have been extremely productive, raising awareness of the persistent burden of hepatitis B, the new, recently implemented CDC guidelines for a universal HBV vaccine recommendation for adults aged 19 to 59 years, and of course, the differentiation and value proposition of PreHevbrio. Over recent months:

We have detailed more than 80% of 3,200 target accounts
60% of Medicare-insured lives, 55% of commercially insured lives, and 50% of lives under state Medicaid plans are estimated to have coverage in place for the PreHevbrio specific Current Procedural Terminology (CPT) code
As we advance through these initial commercial stage gates to establish our target network of distribution partners, we believe that as a differentiated 3-antigen HBV vaccine, PreHevbrio will be a meaningful new tool for healthcare providers as they work to tackle hepatitis B.

In addition to the U.S. launch of PreHevbrio, we continue to meet our clinical and regulatory milestones as we advance our lead pipeline candidates against chronic HBV, GBM, and COVID-19, with three new clinical studies expected to start and new therapeutic HBV Phase 2 data expected before the end of 2022. As VBI’s pipeline now includes both commercial and developmental stage assets, we rigorously prioritize our human and financial capital with efficient and well-managed program execution to maximize the impact of our programs in the medical and public health space, and to drive shareholder value."

Recent Key Program Achievements and Projected Upcoming Milestones

Hepatitis B (HBV)

PreHevbrio [Hepatitis B Vaccine (Recombinant)]

CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation of PreHevbrio published in April 2022 Morbidity and Mortality Weekly Report (MMWR), which also included the updated universal HBV vaccination guidelines for adults aged 19-59
Following marketing authorization in the European Union/European Economic Area and in the United Kingdom, VBI expects to make its 3-antigen HBV vaccine available in select European countries beginning in early 2023 under the name PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)]
Regulatory filing under review by Health Canada
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

Year-end 2022: Interim topline data expected from Phase 2 human proof of concept combination study evaluating safety and efficacy of VBI-2601 (BRII-179) with BRII-835 (VIR-2218), an HBV-targeting siRNA
H1 2023: Interim topline results expected from two-part Phase 2a/2b combination study evaluating VBI-2601 (BRII-179) as an add-on therapy to standard-of-care treatment
Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

June 2022: FDA granted Orphan Drug Designation to VBI-1901 for the treatment of GBM, building on the FDA Fast Track Designation that was granted in June 2021
Q3 2022: Expected initiation of next phase of development in recurrent GBM setting, aiming to expand the number of patients in the ongoing Phase 1/2a study and adding a control arm, with the potential for accelerated approval based on tumor response rates and improvement in overall survival
Q4 2022: Evaluation of VBI-1901 in the primary GBM setting expected to initiate as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial – data from which have potential to support an accelerated approval application
COVID-19 & Coronaviruses

VBI-2901: Trivalent Pan-Coronavirus Vaccine Candidate

Q3 2022: Expected initiation of the first clinical study of VBI-2901, which will be supported through Phase 2 clinical development as part of the Company’s partnership with the Strategic Innovation Fund (SIF) of the Canadian Government, through which up to CAD $56 million was earmarked for VBI’s coronavirus vaccine development program
Second Quarter 2022 Financial Results

Cash Position: VBI ended the second quarter of 2022 with $82.4 million in cash compared with $121.7 million in cash as of December 31, 2021.
Revenue: Revenue for the second quarter of 2022 was $0.3 million, compared to $0.1 million for the same period in 2021. The increase was due to the launch of PreHevbrio in the U.S. at the end of the first quarter of 2022, with revenue generation beginning in the second quarter. Over the coming months, VBI expects to expand the number of customers, continuing to broaden access to PreHevbrio in the U.S.
Cost of Revenue: Cost of revenues was $2.5 million in the second quarter of 2022 as compared to $2.6 million in the second quarter of 2021.
Research and Development (R&D): R&D expenses for the second quarter of 2022 were $5.6 million compared to $4.6 million for the same period in 2021. R&D expenses were offset by $1.0 million in the second quarter of 2022 and $3.3 million in the second quarter of 2021 by government grants and funding arrangements. The increase in R&D expenses is mainly driven by the advancement of VBI-1901 as we prepare for the next clinical studies in recurrent and primary GBM patients.
General and Administrative (G&A): G&A expenses for the second quarter of 2022 were $15.1 million compared to $9.4 million for the same period in 2021. The increase in G&A expenses, partially offset by government grants and funding arrangements, was a result of the increased commercial activities related to our 3-Antigen HBV Vaccine, most notably the deployment of our promotional field team and development of our distribution infrastructure. Additional increased costs include increased insurance costs, increased professional costs, and increased labor costs.
Net Cash Used in Operating Activities: Net cash used in operating activities for the six months ended June 30, 2022, was $37.4 million, compared to $17.4 million for the same period in 2021. The increase was largely due to an increase in net loss attributable to commercial expenses for the launch of PreHevbrio and a decrease in net change in operating working capital as we received $8.3 million of cash in advance from the CEPI Funding Agreement during the six months ended June 30, 2021, compared to $1.0 million cash received in advance from the CEPI Funding Agreement for the same period in 2022.
Net Loss and Net Loss Per Share: Net loss and net loss per share for the second quarter of 2022 were $45.7 million and $0.18, respectively, compared to a net loss of $17.5 million and a net loss per share of $0.07 for the second quarter of 2021.
Net Loss and Net Loss Per Share, Excluding Foreign Exchange Loss: Net loss and net loss per share, excluding foreign exchange loss, for the second quarter of 2022 were $23.8 million and $0.09, respectively, compared to a net loss and a net loss per share, excluding foreign exchange loss, of $17.3 million and $0.07 for the second quarter of 2021. Foreign exchange loss for the second quarter of 2022 was $21.9 million as compared to $0.2 million for the second quarter of 2021. Certain intercompany loans between VBI Vaccines Inc. and our 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.
Use of Non-GAAP Financial Measures

Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss are non-GAAP financial measures. VBI’s management believes that the presentation of Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss is useful to investors because management does not consider foreign exchange loss, which is primarily driven by changes in exchange rates related to certain intercompany loans, when evaluating VBI’s operating performance. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. The presentation of these non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company’s financial statements prepared in accordance with GAAP. Reconciliations of the Company’s non-GAAP measures are included below.

The following represents a reconciliation of Net Loss to Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss.

About PreHevbrio

VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the United States, European Union/European Economic Area, United Kingdom, and Israel. The brand names for this vaccine are: PreHevbrio (US), PreHevbri (EU/EEA, UK), and Sci-B-Vac (Israel).

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

U.S. Indication

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

U.S. Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

On August 8, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy (Press release, Tracon Pharmaceuticals, AUG 8, 2022, View Source [SID1234617799]).

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The Phase 1/2 trial will assess the safety and efficacy of YH001 and envafolimab with or without doxorubicin in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma and in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma.

"With the submission of the IND, we are one step closer to bringing our triple combination of YH001, envafolimab and doxorubicin to front-line sarcoma patients, and pending clearance of the IND, we look forward to initiating the trial before end of this year," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer.

About YH001

YH001, an IgG1 antibody against CTLA-4 invented by Biocytogen, the parent company of Eucure Biopharma, and licensed by TRACON, has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 has been dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

About the Phase 1/2 Clinical Trial of YH001, envafolimab and doxorubicin (NCT05448820)

The Phase 1/2 clinical trial is a multicenter, open label study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by Phase 2 cohorts of patients with select histologies of advanced or metastatic sarcoma, including treatment naive patients. The primary objective of the Phase 1 portion of the trial is to determine the recommended phase 2 dose of YH001 in combination with envafolimab and in combination with envafolimab with doxorubicin. The primary objective of the Phase 2 portion is to determine the objective response rate (ORR) of the combination of YH001 and envafolimab in patients with alveolar soft part sarcoma and chondrosarcoma and the ORR of the combination of YH001, envafolimab and doxorubicin in patients with leiomyosarcoma and dedifferentiated liposarcoma.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

On August 8, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the second quarter ended June 30, 2022 (Press release, Delcath Systems, AUG 8, 2022, View Source [SID1234617798]).

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Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. (PRNewsfoto/Delcath Systems, Inc.)

Recent Business Highlights

During and since the second quarter, Delcath:

Held a pre-NDA meeting with FDA and locked the phase 3 FOCUS Trial database for the purpose of resubmitting the NDA for the Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) in the third quarter of 2022,
Presented a poster updating the results from the FOCUS Trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting,
Opened two Expanded Access Program (NCT05022901) sites, and
Raised $5 million in a private placement priced at market.
In addition, during and since the fourth quarter, independent investigators:

Published Predictive Parameters in Patients Undergoing Percutaneous Hepatic Perfusion with Melphalan for Unresectable Liver Metastases from Uveal Melanoma: A Retrospective Pooled Analysis in the journal Cardiovascular and Interventional Radiology,
Presented two abstracts on the use of Chemosat Hepatic Delivery System with Melphalan in the treatment of metastatic uveal melanoma at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, including:
Safety and efficacy of combined melphalan percutaneous hepatic perfusion (M-PHP) and ipilimumab plus nivolumab (IPI+NIVO) in metastasized uveal melanoma: First results of the phase Ib part of the CHOPIN trial, and
Temporal evolution in quality-of-life following melphalan percutaneous hepatic perfusion for patients with metastatic uveal melanoma.
"As we prepare to resubmit the Hepzato Kit NDA by the end of the third quarter, Chemosat usage in Europe continues to result in publications supportive of both Chemosat and by extension the Hepzato Kit," said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel continued, "We would expect that within 30 days of the resubmission, the FDA will confirm receipt of the submission and, if they agree the resubmission is sufficiently complete to warrant review, establish a PDUFA date sometime late in the first quarter of 2023."

First Quarter 2022 Results

Income Statement Highlights.

Total revenue for the three months ended June 30, 2022, was approximately $0.8 million, compared to $0.5 million for the prior year period, from our sales of CHEMOSAT in Europe. This increase in product revenue is primarily due to a full quarter of direct product sales by Delcath compared to the revenue share arrangement with our distribution partner in Europe in 2021.

Research and development expenses for the quarter were $5.5 million, compared to $3.5 million in the prior year quarter. The growth in R&D expense is primarily due to increased activity related to the NDA preparation. Selling, general and administrative expenses for the quarter were approximately $4.1 million, compared to $3.3 million in the prior year quarter. Total operating expenses for the quarter were $9.6 million, compared with $6.8 million in the prior year quarter.

The Company recorded a net loss for the three months ended June 30, 2022, of $9.7 million, compared to a net loss of $6.4 million for the same period in 2021.

Balance Sheet Highlights

On June 30, 2022, the Company had cash, cash equivalents and restricted cash totaling $14.4 million, as compared to cash, cash equivalents and restricted cash totaling $27.0 million on December 31, 2021. During the three months ended June 30, 2022, and June 30, 2021, we used $6.1 million and $7.1 million, respectively, of cash in our operating activities.

On July 20, 2022, Delcath closed a private placement for the issuance and sale of 690,954 shares of common stock (the "Common Stock") and 566,751 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") to certain investors. Each share of Common Stock was sold at a price per share of $3.98 and the Pre-Funded Warrants were sold at a price of $3.97 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.01 per share of Common Stock and are immediately exercisable. Delcath received gross proceeds from the Private Placement of approximately $5.0 million before deducting offering expenses payable by Delcath. Delcath intends to use the net proceeds from the Private Placement for working capital purposes and other general corporate purposes.

On August 8, 2022 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported financial results for the three months ended June 30, 2022, and highlighted recent progress (Press release, Verastem, AUG 8, 2022, View Source [SID1234617797]).

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"In the second quarter, we announced findings from the interim analysis of our registration-directed RAMP 201 trial in low-grade serous ovarian cancer and are encouraged by the anti-tumor activity that we have seen to date in patients with both KRAS mutant and KRAS wild-type tumors. We look forward to evaluating a more mature data set to select the go forward regimen." said Brian Stuglik, CEO of Verastem Oncology. "We also advanced our broader development program, including being honored by the Pancreatic Cancer Network as the first recipient of their Therapeutic Accelerator Award. This award will support a Phase 1b/2 clinical trial evaluating VS-6766 and defactinib in addition to standard of care chemotherapy in front-line metastatic pancreatic cancer. The goal of the trial is to increase response rate and survival through a more complete blockade of tumorigenic signaling."

Second Quarter 2022 and Recent Highlights

Low Grade Serous Ovarian Cancer (LGSOC)

Verastem Oncology completed a planned interim analysis of the registration-directed RAMP 201 trial with the goal of selecting a go forward treatment regimen of either VS-6766 monotherapy or VS-6766 in combination with defactinib. The analysis indicated encouraging efficacy results with confirmed responses by independent review in patients treated with VS-6766 monotherapy and patients treated with VS-6766 in combination with defactinib. The findings also include confirmed responses by independent review in both KRAS mutant and KRAS wild-type LGSOC. To date, there have been no additional safety signals with a continued favorable safety profile in both the monotherapy and combination treatment arms with approximately 6% of patients discontinuing due to adverse events.
With approximately 80% of patients in the RAMP 201 study remaining on study treatment with a median duration of follow-up of four months, data from the interim analysis were not mature enough to make a final decision on the go forward treatment regimen and the trial continues with all four cohorts. The Company plans to complete enrollment of all four cohorts of the trial in the second half of this year. Each cohort is expected to have approximately 36 patients for a total of 144 patients.
KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)

The registration-directed RAMP 202 study investigating VS-6766 alone and in combination with defactinib continues to enroll patients with V600E or non-V600E BRAF mutations. Planned enrollment is complete in the selection phase (Part A; n=32) in patients with KRAS G12V-mutant NSCLC. Enrollment has also been completed in the non-G12V mutant cohort in the selection phase (Part A). The Company expects to report topline results from Part A, initiate Part B and discuss the data with regulatory authorities during the second half of 2022.
The Phase 1/2 RAMP 204 clinical trial evaluating VS-6766 in combination with Mirati’s adagrasib in KRAS G12C-mutant NSCLC opened and is enrolling participants.
The Phase 1/2 RAMP 203 clinical trial evaluating VS-6766 in combination with Amgen’s LUMAKRASTM (sotorasib) in KRAS G12C-mutant NSCLC continues to enroll and initial results are expected to be reported during the second half of 2022.
Corporate Updates

The U.S Patent and Trademark Office has granted Patent No. 11,400,090 which covers the novel, intermittent twice-weekly dosing regimen used in the VS-6766 development program. This extends the current patent protection for VS-6766 in RAS-driven cancers (KRAS/NRAS/HRAS mutations) to 2038.
The Company received the first "Therapeutic Accelerator Award" from the Pancreatic Cancer Network (PanCAN). The award will support a Phase 1b/2 clinical trial of the Company’s lead investigational candidates, RAF/MEK Clamp, or VS-6766, with FAK inhibitor, defactinib to evaluate whether a more complete blockade of KRAS signaling in addition to standard of care chemotherapy will improve outcomes for patients with front-line metastatic pancreatic cancer. KRAS mutations occurs in more than 95% of pancreatic cancer tumors.
Results from a Phase 1 investigator-initiated trial evaluating RAF/MEK clamp VS-6766 in combination with everolimus presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) found encouraging responses across various RAS-driven tumor types as well as a tolerable intermittent dosing schedule. The data also included a median progression-free survival interval of 6.3 months in KRAS mutant NSCLC and median progression-free survival of 35.8 and 41.8 months in two enrolled patients with KRAS mutant LGSOC, respectively. The trial is continuing with an ongoing expansion cohort for patients with KRAS mutant NSCLC.
Second Quarter 2022 Financial Results

Verastem Oncology ended the second quarter 2022 with cash, cash equivalents and investments of $94.3 million. With proceeds available upon achievement of certain milestones from the Oxford Finance LLC credit facility and expected milestones and royalties from the sale of COPIKTRA, Verastem Oncology expects that it has a cash runway until at least 2025 to deliver on the current programs for VS-6766 and defactinib, including expenditures and development in LGSOC and KRAS mutant NSCLC.

Total revenue for the three months ending June 30, 2022 (2022 Quarter) was $0.0 million, compared to $0.5 million for the three months ended June 30, 2021 (2021 Quarter).

Total operating expenses for the 2022 Quarter were $21.4 million, compared to $16.4 million for the 2021 Quarter.

Research & development expenses for the 2022 Quarter were $14.9 million, compared to $9.7 million for the 2021 Quarter. The increase of $5.2 million, or 53.6%, primarily resulted from an increase in drug product and drug substance costs, contract research organization costs and investigator fees.

Selling, general & administrative expenses for the 2022 Quarter were $6.5 million, compared to $6.7 million for the 2021 Quarter. The decrease of $0.2 million, or 3.0%, primarily resulted from lower consulting and professional fees.

Net loss for the 2022 Quarter was $22.0 million, or $0.12 per share (basic and diluted), compared to net loss of $16.9 million, or $0.10 per share (basic and diluted), for the 2021 Quarter.

For the 2022 Quarter, non-GAAP adjusted net loss was $20.1 million, or $0.11 per share (diluted), compared to non-GAAP adjusted net loss of $14.0 million, or $0.08 per share (diluted), for the 2021 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.

Use of Non-GAAP Financial Measures

To supplement Verastem Oncology’s condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), the Company uses the following non-GAAP financial measures in this press release: non-GAAP adjusted net (loss) income and non-GAAP net (loss) income per share. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with the Company’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to the Company’s operating performance and can enhance investors’ ability to identify operating trends in the Company’s business. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company’s operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three and six months ended June 30, 2022, and 2021 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.

In contrast to other MEK inhibitors, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.1

Verastem Oncology is conducting Phase 2 registration-directed trials of VS-6766 alone and with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS G12V-mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials, RAMP 201 and RAMP 202, respectively. Verastem Oncology has also established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and adagrasib in combination with VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively.

On August 8, 2022 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for cancer patients suffering from solid tumors, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, TCR2 Therapeutics, AUG 8, 2022, View Source [SID1234617796]).

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"TCR2 made significant strides this quarter in preparation for our upcoming gavo-cel Phase 1 and TC-510 data expected in the second half of 2022. As part of our commitment to deliver a meaningfully interpretable dataset, we plan to present our gavo-cel Phase 1 trial data on at least 30 patients in September in order to collect additional scans on patients evaluable for efficacy," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We also continue to expect to present initial safety, efficacy and translational data from our TC-510 Phase 1 clinical trial before the end of 2022. In connection with progressing our two mesothelin-focused clinical trials, we have activated additional clinical sites and expanded our manufacturing capacity through ElevateBio BaseCamp. This will allow us to further accelerate the pace at which we can deliver our unique cell therapy to benefit patients suffering from solid tumors."

Recent Developments

TC-510:

TCR2 initiated the Phase 1 dose escalation portion of the Phase 1/2 clinical trial of TC-510, its first enhanced mesothelin-targeted TRuC-T cell that co-expresses a PD-1:CD28 chimeric switch receptor. Enrollment is ongoing and the Company expects to report on initial safety, efficacy and translational data from at least one of the Phase 1 dose escalation cohorts of the Phase 1/2 clinical trial in the second half of 2022.
Corporate:

TCR2 announced the appointment of industry and finance veteran Eric Sullivan as Chief Financial Officer where he will be responsible for leading all aspects of financial management and capital market strategy as well as overseeing investor relations and select business operations.
Manufacturing:

TCR2 announced today the commencement of clinical trial material production at ElevateBio BaseCamp in anticipation of increased demand from the Phase 2 expansion trial of gavo-cel.
Anticipated Milestones

Gavo-cel:

Present the expanded Phase 1 dataset for gavo-cel in September 2022.
Provide an update from the Phase 2 portion of the ongoing gavo-cel Phase 1/2 clinical trial in the second half of 2022.
TC-510:

Report initial safety, efficacy and translational data from at least one of the Phase 1 dose escalation cohorts of the TC-510 Phase 1/2 clinical trial in the second half of 2022.
Pipeline:

Initiate IND-enabling studies for TC-520, an enhanced CD70 targeting TRuC-T cell program, in 2022.
Financial Highlights

Cash Position: TCR2 ended the second quarter of 2022 with $206.2 million in cash, cash equivalents, and investments compared to $265.6 million as of December 31, 2021. Net cash used in operations was $19.5 million for the second quarter of 2022 compared to $15.0 million for the second quarter of 2021. TCR2 projects net cash use of $115-125 million for 2022. We expect cash on hand to support operations into 2024.

R&D Expenses: Research and development expenses were $25.8 million for the second quarter of 2022 compared to $18.6 million for the second quarter of 2021. The increase in R&D expenses was primarily due to an increase in contract manufacturing costs and clinical trial expenses associated with patient treatment and headcount.

G&A Expenses: General and administrative expenses were $6.0 million for the second quarter of 2022 compared to $5.7 million for the second quarter of 2021. The increase in general and administrative expenses was due to an increase in personnel costs and other professional fees.

Net Loss: Net loss was $31.6 million for the second quarter of 2022 compared to $24.3 million for the second quarter of 2021.
Upcoming Events

TCR2 Therapeutics management is scheduled to participate at the following upcoming conferences.

Wedbush PacGrow Healthcare Conference: Management will participate in investor one-on-one meetings on August 10, 2022