On August 9, 2022 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported financial results and provided a business update for the quarter ended June 30, 2022 (Press release, Immatics, AUG 9, 2022, View Source [SID1234617873]).

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"Immatics has now initiated all three IMA203 TCR-T Phase 1b expansion cohorts with the objective to deliver durable objective responses in heavily pre-treated solid cancer patients. Our IMA203 TCR-T therapy as well as IMA402, our TCR Bispecific, both target a PRAME peptide which represents one of the most promising and prevalent targets in the solid cancer space," commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "We are also very excited to have recently announced two new agreements with Bristol Myers Squibb and Editas Medicine that strengthen our capabilities in the field of allogeneic gamma delta T cell therapies. By combining our strengths through such partnerships, we can accelerate the development of our pipeline and increase its potential to deliver a meaningful impact on the lives of cancer patients."

Second Quarter 2022 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA203 (PRAME) – Following interim results from the IMA203 monotherapy during Phase 1a dose escalation, Immatics has extended the clinical trial to three Phase 1b expansion cohorts to realize a high rate of durable responses with TCR-T against PRAME.

Cohort A – IMA203 as monotherapy at the provisional recommended Phase 2 dose (RP2D) plus exploration of a higher dose level (dose level 5, DL5; up to 4.7 billion transduced CD8 T cells per m² body surface area)
Cohort B – IMA203 in combination with the PD-1 immune checkpoint inhibitor Opdivo (nivolumab)
Cohort C – IMA203CD8, a 2nd generation monotherapy where IMA203 is co-expressed with a CD8 co-receptor to leverage functional CD4 T cells in addition to CD8 T cells in the anti-tumor response

As per the respective announcements made in March and May, the first patients have been treated in Cohort A and Cohort B, with the first patient expected to be treated in Cohort C in August, 2022. The next data readout for the IMA203 monotherapy cohort at RP2D is expected for 2H 2022 and an initial data readout for Cohort B and Cohort C is planned for YE2022.

ACTallo – On June 2nd, 2022, Immatics announced a multi-program collaboration with Bristol Myers Squibb to develop allogeneic TCR-T/CAR-T programs. Immatics received an upfront payment of $60 million and is eligible for up to $700 million per Bristol Myers Squibb program through milestone payments and tiered royalties. Under the collaboration agreement, Bristol Myers Squibb receives access to Immatics’ proprietary gamma delta T cell-derived allogeneic Adoptive Cell Therapy (ACT) platform, ACTallo, and can bring in up to 4 TCR-T targets based on the 2019 collaboration agreement or CAR-T targets. Immatics receives access to Bristol Myers Squibb’s next-generation technologies. The companies will work together to develop and commercialize two of Bristol Myers Squibb’s allogeneic TCR-T/CAR-T programs. Under the terms of the collaboration, both companies have an option to develop up to four additional programs each. Immatics may also develop additional allogeneic programs based on its ACTallo platform outside of the collaboration.

ACTallo – Immatics entered a strategic research collaboration and licensing agreement with Editas Medicine, Inc., combining gamma delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer. As part of the agreement, Immatics gains non-exclusive rights to Editas Medicine’s CRISPR technology and intellectual property.

Autologous TCR-T – Immatics and Bristol Myers Squibb expanded their autologous T cell receptor-based therapy (TCR-T) collaboration signed in 2019 by including one additional TCR-T target discovered by Immatics. Immatics received a payment of $20 million and is eligible for milestone payments as well as royalties.

ACTengine IMA201 (MAGEA4/A8) – The Phase 1a dose escalation cohort is ongoing and is expected to be completed by YE2022.

TCR Bispecifics Programs

Immatics’ TCER candidates are next-generation, half-life extended TCR Bispecific molecules designed to maximize efficacy while minimizing toxicities in patients through its proprietary format using a low-affinity T cell recruiter and a high-affinity TCR domain.

TCER IMA401 (MAGEA4/8) – On May 10, 2022, Immatics announced the initiation of its Phase 1 trial evaluating the company’s most advanced T cell engaging receptor (TCER) IMA401 in patients with recurrent and/or refractory solid tumors. The Phase 1 clinical trial is expected to include approximately 50 patients at up to 15 centers in Germany. IMA401 is developed in collaboration with Bristol Myers Squibb.

TCER IMA402 (PRAME) – A preclinical data update will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting (September 9-13, 2022). Manufacturing of the clinical batch is on track for 2H 2022 and initiation of the Phase 1 trial is planned in 2023.

Corporate Developments

Board of Directors Update

At Immatics’ Annual General Meeting in June 2022, Nancy Valente, M.D., was elected as a member of the company’s Board of Directors. Dr. Valente brings over 20 years of experience in oncology and hematology drug development. In her last position at Genentech/Roche, she was Senior Vice President, Oncology Product Development, where she helped to build a diverse portfolio of new oncology therapies encompassing small molecules, antibodies, bispecific antibodies and antibody drug conjugates. Additional information on all members of Immatics’ Board of Directors can be found on the Immatics website.

Second Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €324.4 million ($337.0 million1) as of June 30, 2022, compared to €252.7 million ($262.5 million1) as of March 31, 2022. The increase is mainly due to the receipt of the upfront payment in connection with the collaboration agreement with Bristol Myers Squibb on allogeneic ACT as well as the addition of one additional autologous TCR-T target as part of a 2019 collaboration agreement, partly offset by the financing of our ongoing research and development activities. With the addition of these upfront payments, the Company projects a cash runway into 2H 2024.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €17.2 million ($17.9 million1) for the three months ended June 30, 2022, compared to €5.2 million ($5.4 million1) for the three months ended June 30, 2021. The increase is mainly related to the increased recognition of revenue for the multiple collaboration agreements Immatics has in place.

Research and Development Expenses: R&D expenses were €25.2 million ($26.2 million1) for the three months ended June 30, 2022, compared to €20.3 million ($21.1 million1) for the three months ended June 30, 2021. The increase is mainly related to increased spending on clinical trials.

General and Administrative Expenses: G&A expenses were €8.7 million ($9.0 million1) for the three months ended June 30, 2022, compared to €8.3 million ($8.6 million1) for the three months ended June 30, 2021.

Net Income/Loss: Net loss was €14.0 million ($14.5 million1) for the three months ended June 30, 2022, compared to a net loss of €26.5 million ($27.5 million1) for the three months ended June 30, 2021. The decrease was primarily the result of the increased revenue from multiple collaboration agreements.

Full financial statements can be found in the current report on Form 6-K filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of June 30, 2022 (1 EUR = 1.0387 USD).

Upcoming Investor Conferences

Jefferies Cell and Genetic Medicine Summit, New York – September 29-30, 2022
Jefferies London Healthcare Conference, London, U.K. – November 15-17, 2022
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

On August 9, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a biotherapeutics company dedicated to changing the treatment paradigm for patients with devastating diseases, reported that it has raised aggregate proceeds of up to approximately $115.4 million, net of transaction fees, through the sale of shares of its Founded Entity, Karuna Therapeutics ("Karuna," Nasdaq: KRTX), comprising a sale of 125,000 Karuna shares in on-market transactions and expected completion of call options covering up to 477,100 Karuna shares (collectively, the "Transaction") (Press release, PureTech Health, AUG 9, 2022, View Source [SID1234617872]). PureTech intends to use the proceeds from the Transaction to further the advancement and growth of the Company and will update its cash runway guidance in its half-yearly results for the six months ended June 30, 2022, to be announced on August 25, 2022.

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Following the Transaction and presuming the exercise of all call options written by the Company, PureTech will have generated an aggregate total of approximately $681.1 million in sales of Karuna equity since Karuna’s initial public offering. PureTech will continue to hold 1,054,464 shares of Karuna common stock, which is equal to approximately 3.5% of Karuna’s outstanding shares as of August 3, 2022, with a market value of approximately $254.3 million as of market close on August 8, 2022.

Additionally, as the founder of Karuna and co-inventor of the KarXT program, PureTech also has a right to royalty payments of 3% of net sales of any commercialized product as well as 20% of sublicense income covered by the license agreement. The license agreement covers the KarXT program in key territories including the United States, European Union, and Japan. PureTech is also eligible to receive certain milestone payments upon the achievement of regulatory approvals.

The Transaction constitutes a class 2 transaction for the purposes of the UK Financial Conduct Authority’s Listing Rules.

On August 9, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and LIFENET INSURANCE COMPANY (Headquarters: Tokyo, President: Ryosuke Mori, "LIFENET") reported that they have entered into a capital and business alliance agreement to collaborate in dementia and other areas, with the aim of helping reduce the burden of medical and nursing care for people living in Japan’s aging society (Press release, Eisai, AUG 9, 2022, View Source [SID1234617862]).

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New insurance products and services will be developed by mutually leveraging Eisai’s wealth of experience and network in drug discovery and disease awareness activities in the field of dementia, which it has built up over many years, and LIFENET’s know-how and technologies cultivated in insurance products and related services. Furthermore, Eisai and LIFENET will promote the creation of healthcare solutions utilizing various data and customer touchpoint owned by both companies, and expand the ecosystem that contributes to solving social issues. Under the terms of the agreement, Eisai will obtain LIFENET common stock worth 300 million yen through market transaction.

Under the medium-term business plan"EWAY Future & Beyond", which began in April 2021, Eisai is expanding its main role in healthcare, that is, we should contribute not only to people in the medical domain but also to people in the daily living domain. Eisai aim’s to evolve into a company that empowers them "to realize their fullest life" by creating solutions based on science and data in the fields with high unmet medical needs where Eisai has the greatest strength, through an ecosystem developed in collaboration with other industries. This alliance will accelerate the building of a dementia ecosystem that contributes through prevention, treatment, and aftercare in a comprehensive manner.

LIFENET has worked with other industry partners to provide products and services that meet the needs of the times. Through this alliance, as stated in LIFENET Manifesto, LIFENET will continue providing health and wellness tips beyond the framework of life insurance to create value in our policyholders’ lives, while creating a precedent for future generations as to what life insurance is (and should be) all about.

Eisai and LIFENET will contribute to solving social issues through the creation of an ecosystem while pursuing the possibility of collaborations with other companies and organizations that support the objectives of the two companies’ activities.

On August 9, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the second quarter ended June 30, 2022 (Press release, Cogent Biosciences, AUG 9, 2022, View Source [SID1234617861]).

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"In the second quarter we achieved a number of important milestones as we continued to advance bezuclastinib and grow the research and development pipeline," said Andrew Robbins, President and CEO of Cogent Biosciences. "Most notably, we reported positive initial clinical data from our APEX trial that strengthened our belief in bezuclastinib’s potential to provide meaningful clinical activity for systemic mastocytosis patients, without the tolerability challenges seen with other available treatment options. We remain on track to provide another clinical update from this trial by the end of 2022. We are equally excited about the opportunity with bezuclastinib in non-advanced systemic mastocytosis and gastrointestinal stromal tumor (GIST) patients and expect to provide clinical data updates on these programs during the first half of 2023. Based on the positive APEX data, we were able to secure additional financing at the end of the quarter, and we are confident this will support our go forward strategy into 2025."

Recent Business Highlights

In June 2022, Cogent reported positive initial data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor, bezuclastinib, in patients with advanced systemic mastocytosis (AdvSM).
As of the data cutoff date, May 24, 2022, all 11 patients treated were evaluated for signs of clinical activity. Bezuclastinib demonstrated rapid reductions in serum tryptase, with all patients achieving a ≥50% reduction (10/11 achieved within the first week of treatment) and 6/11 achieving serum tryptase <20ng/mL. All patients remained on treatment with treatment duration ranging from 0.5 – 4.8 months. Bezuclastinib was generally well-tolerated at all doses with no reported periorbital or peripheral edema, cognitive effects or intracranial bleeding events.
In April 2022, the Company presented early data and outlined its strategy to create best-in-class small molecules from the company’s growing pipeline of novel, targeted therapy programs at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and company sponsored R&D investor event.
Announced plans to advance a potent, selective FGFR2 inhibitor toward candidate selection with a product profile that includes best-in-class selectivity against all known FGFR2 primary driver and secondary resistance mutations.
Announced development of an ErbB2 mutant selective inhibitor for patients with mutations that are not well addressed by therapies currently approved or in clinical development.

Appointed Fang Fang, Ph.D., Vice President, Biometrics in Development Operations.

Dr. Fang joins Cogent with over 20 years of industry experience and leadership in oncology biometrics and biostatistics. Prior to joining, she was Vice President, Biometrics at Kiniksa Pharmaceuticals. Earlier in her career, Dr. Fang held roles of increasing responsibility at Merrimack Pharmaceuticals, Bayer Healthcare, Eisai Medical Research and Astellas Pharma. Dr. Fang received her Ph.D. in Biostatistics from Rutgers University.
Upcoming Milestones

Present additional data from APEX, a global, multicenter Phase 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) by the end of 2022.

Present initial data from SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial with bezuclastinib for nonadvanced systemic mastocytosis (NonAdvSM) in the first half of 2023.

Present lead-in data from PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with gastrointestinal stromal tumors (GIST), in the first half of 2023.

File first internally developed Investigational New Drug application (IND) from Cogent’s potent, selective FGFR2 inhibitor program in the second half of 2023.

Second Quarter 2022 Financial Results

Cash Position: As of June 30, 2022, cash and cash equivalents were $325.6 million, as compared to $191.0 million as of March 31, 2022. The company believes that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2025.

R&D Expenses: Research and development expenses were $29.5 million for the second quarter of 2022 as compared to $12.4 million for the second quarter of 2021. The increase was primarily due to costs associated with the on-going APEX, SUMMIT and PEAK clinical trials and costs related to expanding the Cogent Research Team, which was formed in the second quarter of 2021. R&D expenses include non-cash stock compensation expense of $2.1 million for the second quarter of 2022 compared to $1.0 million for the second quarter of 2021.

G&A Expenses: General and administrative expenses were $6.4 million for the second quarter of 2022 as compared to $4.9 million for the second quarter of 2021. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $2.4 million for the second quarter of 2021 compared to $1.6 million for the second quarter of 2021.

Net Loss: Net loss was $34.9 million for the second quarter of 2022 as compared to a net loss of $16.5 million for the same period of 2021.

On August 9, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we" or "our") reported its second-quarter 2022 financial results (Press release, Bausch Health, AUG 9, 2022, View Source [SID1234617860]).

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"The second quarter was a transitional quarter for Bausch Health as we intensified our focus on the Bausch Pharma and Solta businesses," Thomas J. Appio, Chief Executive Officer, Bausch Health, said. "In our first ninety days, our leadership team has taken immediate action to strengthen execution and accelerate change. We have advanced debt paydown through open market repurchases this quarter. We are focused on creating value through driving growth, profitability and improving our balance sheet."

Strategic Alternatives Update
The Company believes that spinning off Bausch + Lomb makes strategic sense and it remains committed to doing so as soon as it is able to satisfy all applicable conditions as previously disclosed. The Company is evaluating all relevant factors and considerations regarding the distribution as it assesses the potential impacts of the Norwich XIFAXAN patent litigation.

Second-Quarter 2022 Revenue Performance
Total reported revenues were $1.967 billion for the second quarter of 2022, as compared to $2.1 billion in the second quarter of 2021, a decrease of $133 million, or 6%. Excluding the unfavorable impact of foreign exchange of $61 million and the impact of divestitures and discontinuations of $74 million, primarily due to the divestiture of Amoun Pharmaceutical Company S.A.E. ("Amoun") on July 26, 2021, revenue was flat on an organic basis1,2 compared to the second quarter of 2021.

Reported revenues by segment were as follows:

Salix Segment
Salix segment reported and organic1,2 revenues were $501 million for the second quarter of 2022, as compared to $516 million for the second quarter of 2021, a decrease of $15 million, or 3%. The decrease was primarily driven by a decline in sales of TRULANCE and certain non-promoted products, partially offset by increased sales of XIFAXAN and PLENVU.

International Segment3
International segment reported revenues were $233 million for the second quarter of 2022, as compared to $313 million for the second quarter of 2021, a decrease of $80 million, or 26%. Excluding the unfavorable impact of foreign exchange of $15 million and the impact of divestitures and discontinuations of $71 million, primarily from the divestiture of Amoun, segment revenues increased organically1,2 by 2% compared to the second quarter of 2021. 2022 includes a provision for expected future product returns of $11 million. Excluding the impact of this returns provision, segment revenues increased by 7% on an organic1,2 basis.

Diversified Products Segment3
Diversified Products segment reported and organic1,2 revenues were $235 million for the second quarter of 2022, as compared to $264 million for the second quarter of 2021, a decrease of $29 million, or 11%, primarily attributable to a decrease in volumes attributable to the neurology business and lower net realized pricing. Revenues from Jublia increased 13% as the brand continues to benefit from marketing investment.

Solta Medical Segment3
Solta Medical segment reported and organic1,2 revenues were $57 million for the second quarter of 2022, as compared to $73 million in the second quarter of 2021, a decrease of $16 million, or 22%. Ongoing COVID-related lockdowns in China drove the decline.

Bausch + Lomb Segment3
Bausch + Lomb segment reported revenues were $941 million for the second quarter of 2022, as compared to $934 million for the second quarter of 2021, an increase of $7 million, or 1%. Excluding the unfavorable impact of foreign exchange of $46 million and the impact of divestitures and discontinuations of $3 million, the Bausch + Lomb segment revenue increased organically1,2 by 6% compared to the second quarter of 2021, driven by sales growth in Vision Care and Surgical, offset by lower revenues from Ophthalmic Pharmaceuticals.

Operating Income/Loss
Operating income was $161 million for the second quarter of 2022, as compared to an operating loss of $270 million for the second quarter of 2021, a favorable change of $431 million, primarily driven by a decrease in Other expense, primarily attributable to higher adjustments related to the settlement of certain litigation matters in the second quarter of 2021 and lower amortization of intangible assets in 2022, partially offset by an impairment to goodwill in 2022.

Net Loss Attributable to Bausch Health
Net loss attributable to Bausch Health for the second quarter of 2022 was $145 million, as compared to $595 million for the second quarter of 2021, a favorable change of $450 million as a result of the change in operating results discussed above and a net gain on extinguishment of debt in 2022, partially offset by an increase in the provision for income taxes and higher interest expense.

Adjusted net income attributable to Bausch Health (non-GAAP)1 for the second quarter of 2022 was $201 million, as compared to $352 million for the second quarter of 2021, a decrease of $151 million primarily due to the investment of Amoun, lower gross profit due to sales performance and inflation, higher operating expenses (investments in sales and marketing and research and development) and higher interest and income tax expense.

Earnings Per Share Attributable to Bausch Health
GAAP Earnings Per Share attributable to Bausch Health for the second quarter of 2022 was ($0.40), as compared to ($1.66) for the second quarter of 2021.

Adjusted EBITDA attributable to Bausch Health (non-GAAP)1
Adjusted EBITDA attributable to Bausch Health (non-GAAP)1 was $701 million for the second quarter of 2022, as compared to $826 million for the second quarter of 2021, a decrease of $125 million, primarily due to the divestment of Amoun, lower gross profit as discussed above and higher investments in sales and marketing and research and development.

Cash Provided by Operating Activities
The Company generated cash provided by operating activities of $123 million in the second quarter of 2022, as compared to $395 million in the second quarter of 2021, a decrease of $272 million due to business results and changes in working capital.

Balance Sheet Highlights as of June 30, 2022:

Cash, cash equivalents, restricted cash and other settlement deposits were $1.879 billion5.
The Company executed an open market repurchase program in the second quarter in which the Company purchased $481 million of unsecured bonds for $300 million of cash consideration.
Bausch Health had availability under its 2027 Revolving Credit Facility of approximately $500 million and Bausch + Lomb had availability of approximately $500 million under its Revolving Credit Facility.
2022 Financial Outlook
Bausch Health updated its consolidated guidance for the full year 2022 as follows:

Full year revenue range of $8.05 – $8.22 billion compared to prior guidance of $8.25 – $8.40 billion
Full year Adjusted EBITDA (non-GAAP)1 range of $3.02 – $3.12 billion compared to prior guidance of $3.225 – $3.375 billion
Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP)1 to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP)1. These statements represent forward-looking information and may represent a financial outlook, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release. The guidance in this news release is only effective as of the date given, August 9, 2022, and will not be updated or affirmed unless and until the Company publicly announces updated or affirmed guidance.