Adaptimmune to Report Q1 2022 Financial Results and Business Updates on Monday, May 9, 2022

On April 28, 2022 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that will report financial results and provide business updates for the first quarter ended March 31, 2022, before the US markets open on Monday, May 9, 2022 (Press release, Adaptimmune, APR 28, 2022, View Source [SID1234613237]). Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) that same day.

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The press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. A live webcast of the conference call and replay can be accessed at https://bit.ly/3k8uZcI.

To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (6779362).

Kelonia Therapeutics Launches with $50 Million Series A Financing to Pioneer Precision Targeted Genetic Medicines

On April 28, 2022 Kelonia Therapeutics, a biotech company revolutionizing in vivo gene delivery, launched with a $50 million Series A financing to usher in a new era of genetic medicines for a wide range of diseases (Press release, Kelonia Therapeutics, APR 28, 2022, Kelonia Therapeutics Launches with $50 Million Series A Financing to Pioneer Precision Targeted Genetic Medicines [SID1234640176]). Kelonia’s platform overcomes the central challenge that has prevented the full realization of gene therapy for patients. Despite life-changing responses, existing gene therapies are highly complex, costly, and limited by complicated treatment paradigms, tractable therapeutic applications, and dose-limiting toxicities. By enabling precisely targeted, highly efficient, manufacturable "off-the-shelf" in vivo gene delivery, Kelonia’s technology has the potential to dramatically expand the impact and reach of genetic medicines to every patient in need.

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Kelonia is backed by a strong syndicate of investors with a track record of successfully launching and building disruptive biotech companies. Alta Partners, Horizons Ventures, Venrock and other investors participated in the Series A round. The company will use the funding to redefine what’s possible for genetic medicines starting with an "off-the-shelf" chimeric antigen receptor (CAR) to treat hematologic cancer that may enable the unrivalled clinical benefit of CAR T without the typical toxicities and with the ease of access of conventional medicines. Additionally, the company will advance other programs for oncology and non-oncology indications, and further expand its gene delivery platform and capabilities.

"The cell and gene therapy field has been searching for solutions to durable in vivo genetic modifications regardless of whether applying gene editing, RNA expression or viral-mediated gene integration," said Kevin Friedman, Ph.D., President and Chief Scientific Officer of Kelonia. "At Kelonia, we believe we have found an in vivo gene delivery solution that is safe, effective, and manufacturable for broad therapeutic application. With our Series A funding and key strategic collaborations, we will advance our lead product candidate toward clinical studies and further optimize our technology to explore treating diseases never thought possible with genetic medicines."

Based on discoveries made in the lab of Massachusetts Institute of Technology’s Michael Birnbaum, Ph.D., and leveraging pioneering research from leading scientists at the French National Centre for Scientific Research (CNRS), Kelonia’s in vivo gene delivery technology enables a few potent lentiviral vector-like particles armed with an adjustable targeting system to precisely, efficiently, and safely deliver payloads exactly where needed to treat a broad range of diseases. The company’s early applications combine oncology-targeted therapeutics, such as CAR and T cell receptor molecules, with Kelonia’s precision in vivo targeting technology. When used in concert, this combination enables potent and precise tumor targeting with limited "off-tumor" toxicity, which would otherwise be a concern. Administered directly in vivo as an "off-the-shelf" medicine, Kelonia’s transformational therapies in development for solid and hematologic tumors have the potential to democratize patient access to genetic medicines. Beyond oncology, the company will advance its technology to unlock delivery to previously hard-to-reach tissues, such as neurological, muscular or renal, to deliver different types of genetic cargo with the goal of radically transforming the treatment of diseases in these areas.

"It turns out, a relatively simple and elegant idea to de-target and redirect lentivirus-like particles based on recently published research from my lab can potentially provide a solution to in vivo gene delivery," said Dr. Birnbaum, Ph.D., Co-Founder of Kelonia. "I’m incredibly excited about the potential of Kelonia’s platform and team to vastly expand the utility of gene therapies to treat oncology, autoimmune disease, rare monogenic or other diseases currently intractable to gene therapies."

"Kelonia is combining the two crucial elements required to develop truly novel medicines: breakthrough biology and an exceptional team," said Bryan Roberts, Partner at Venrock. "Michael Birnbaum’s industrially robust platform affords a targeting specificity log orders better than anything else out there and the team has a stellar track record for translating groundbreaking scientific gene therapy discoveries into viable products that are transformative for patients."

Strategic Collaborations

In addition to the completion of its Series A, Kelonia has established strategic collaborations with Adimab and ElevateBio. With both collaborations already successfully underway, each of these outstanding partners brings differentiating capabilities that enable and accelerate the company’s vision to bring breakthrough genetic medicines to patients.

Adimab is the leading provider of therapeutic antibody discovery and engineering technologies. Kelonia will leverage Adimab’s expertise and proprietary technologies, across a range of applications, to access tissue-specific antibodies that enable unlocking precise in vivo gene delivery to different tissues as well as antibodies that can be leveraged within the therapeutic genetic cargo.

ElevateBio is a technology-driven company focused on powering transformative cell and gene therapies with multiple next-generation technology platforms and a fully integrated R&D and manufacturing facility. Through an expanding partnership, Kelonia will utilize ElevateBio’s lentiviral vector platform, process and analytical development expertise, and cGMP manufacturing capabilities to develop and advance novel manufacturing processes for Kelonia and manufacture of Kelonia’s products.

Labcorp Announces 2022 First Quarter Results Company Raises Full-Year Revenue and EPS Guidance

On April 28, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported results for the first quarter ended March 31, 2022, and updated full-year guidance (Press release, LabCorp, APR 28, 2022, View Source [SID1234613109]).

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"Labcorp continues to advance our strategy through science, innovation and technology," said Adam Schechter, chairman and CEO of Labcorp. "We delivered a solid first quarter despite the impact of Omicron. We remain focused on growth opportunities while continuing to take actions to mitigate inflation. Our base business performance coming out of the quarter positions us well for continued success throughout the year."

During the quarter, Labcorp launched the Labcorp OnDemand digital health platform, intensifying its consumer focus and enhancing the user experience. The company made strides in oncology, including through key collaborations and closing its acquisition of Personal Genome Diagnostics (PGDx). Labcorp also entered into and expanded several strategic relationships with hospitals and health systems, including agreements to purchase select outreach laboratory business assets.

The company announced a quarterly dividend of $0.72 per share of common stock, which will be payable June 9, 2022, to stockholders of record at the close of business on May 19, 2022. In addition, Labcorp published its 2021 Corporate Responsibility Report which underscores its commitment to pursuing responsible, ethical and sustainable operations.

Consolidated Results

First Quarter Results

Revenue for the quarter was $3.90 billion, a decrease of (6.3%) from $4.16 billion in the first quarter of 2021. The decrease was due to organic revenue of (6.3%) and foreign currency translation of (0.4%), partially offset by acquisitions net of divestitures of 0.4%. The (6.3%) decline in organic revenue was driven by a (9.8%) decrease in COVID-19 PCR and antibody testing (COVID-19 Testing), partially offset by a 3.5% increase in the company’s organic Base Business. Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $687.9 million, or 17.6% of revenue, compared to $1,057.9 million, or 25.4%, in the first quarter of 2021. The company recorded amortization, restructuring charges, and special items, which together totaled $106.1 million in the quarter, compared to $124.0 million during the same period in 2021. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $794.0 million, or 20.4% of revenue, compared to $1,181.9 million, or 28.4%, in the first quarter of 2021. The decrease in operating income and margin was primarily due to a reduction in COVID-19 Testing, higher personnel expense, and other inflationary costs, partially offset by organic Base Business growth and LaunchPad savings.

Net earnings for the quarter were $491.6 million compared to $769.6 million in the first quarter of 2021. Diluted EPS were $5.23 in the quarter compared to $7.82 during the same period in 2021. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $6.11 in the quarter compared to $8.79 in the first quarter of 2021.

Operating cash flow for the quarter was $356.0 million compared to $1,157.6 million in the first quarter of 2021. The decrease in operating cash flow was due to lower cash earnings and higher working capital requirements. Capital expenditures totaled $117.2 million compared to $95.4 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $238.8 million compared to $1,062.2 million in the first quarter of 2021.

At the end of the quarter, the company’s cash balance and total debt were $1.2 billion and $5.4 billion, respectively. During the quarter, the company invested $455.1 million on acquisitions. As part of the company’s accelerated stock repurchase program initiated in December 2021, 0.6 million shares were retired during the quarter.

First Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics

Revenue for the quarter was $2.45 billion, a decrease of (11.0%) from $2.76 billion in the first quarter of 2021. The decrease was due to organic revenue of (11.5%), partially offset by acquisitions of 0.5%. The (11.5%) decrease in organic revenue was due to a (14.7%) reduction from COVID-19 Testing, partially offset by a 3.2% increase in the Base Business. Total Base Business growth compared to the Base Business in the prior year was 5.6%.

Total volume (measured by requisitions) decreased by (5.0%) as organic volume decreased by (5.3%) and acquisition volume contributed 0.3%. Organic volume was impacted by a (8.5%) decrease in COVID-19 Testing, partially offset by a 3.1% increase in Base Business. Price/mix decreased by (6.0%) due to a decrease in COVID-19 Testing of (6.3%), partially offset by acquisitions of 0.2% and organic Base Business growth of 0.1%. Base Business volume was up 4.4% compared to the Base Business last year, while price/mix was up 1.2%.

Adjusted operating income for the quarter was $683.1 million, or 27.8% of revenue, compared to $991.6 million, or 36.0%, in the first quarter of 2021. The decrease in adjusted operating income and adjusted operating margin was primarily due to a reduction in COVID-19 Testing, higher personnel expense, and other inflationary costs, partially offset by organic Base Business growth and LaunchPad savings.

Drug Development

Revenue for the quarter was $1.46 billion, an increase of 1.5% from $1.44 billion in the first quarter of 2021. The increase was due to organic Base Business growth of 4.3% and acquisitions net of divestitures of 0.1%, partially offset by lower COVID-19 Testing of (1.7%) and foreign currency translation of (1.2%).

Adjusted operating income for the quarter was $168.6 million, or 11.6% of revenue, compared to $234.1 million, or 16.3%, in the first quarter of 2021. Adjusted operating income and margin declined primarily due to COVID-19 Testing, a reduction in COVID-19 vaccine and therapeutic work, the interruption of some clinical trial activity due to the conflict in Ukraine, higher personnel expense, and other inflationary costs. These impacts were partially offset by organic Base Business growth and LaunchPad savings.

Net orders and net book-to-bill during the trailing twelve months were $7.20 billion and 1.23, respectively. Backlog at the end of the quarter was $15.19 billion, an increase of 8.7% compared to last year. The company expects approximately $4.95 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2022

Labcorp is updating 2022 full year guidance to reflect its first quarter performance and full-year outlook. The following guidance assumes foreign exchange rates effective as of March 31, 2022, for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends.

(Dollars in billions, except per share data)

(1) 2022 Updated Guidance includes an impact from foreign currency translation of (0.4%), previous 2022 Guidance was (0.2%)

(2) Enterprise level revenue is presented net of intersegment transaction eliminations, including Drug Development COVID-19 Testing revenue

(3) 2022 Updated Guidance includes an impact from foreign currency translation of 0.0%, previous 2022 Guidance was (0.1%)

(4) 2022 Updated Guidance includes an impact from foreign currency translation of (1.1%), previous 2022 Guidance was (0.4%)

(5) Free Cash Flow consists of operating cash flow less capital expenditures

Use of Adjusted Measures

The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by dialing 877-825-4844 (631-813-4900 for international callers). The conference ID is 2386657. A telephone replay of the call will be available through May 12, 2022, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The conference ID for the replay is 2386657. A live online broadcast of Labcorp’s quarterly conference call on April 28, 2022, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This online broadcast will be archived and accessible through April 14, 2023.

IMV’s Lead Compound to Be Showcased in Two Presentations at the 2022 ASCO Annual Meeting

On April 28, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported the Company’s lead compound, maveropepimut-S (MVP-S), will be showcased in two presentations in breast and ovarian cancer at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, IMV, APR 28, 2022, View Source [SID1234613129]). The meeting will be held in-person and virtually June 3-7, 2022, in Chicago, Illinois.

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Presentation Details

Neoadjuvant Survivin-targeted Immunotherapy Maveropepimut-S (MVP-S) to increase Th1 Immune Response in Ki67-high Hormone Receptor Positive (HR+) Early-stage Breast Cancer (ESBC)

Presenter: Sasha E. Stanton, M.D., Ph.D., Medical Oncologist and Assistant member, Cancer Immunoprevention Laboratory Earle A. Chiles Research Institute at the Providence Cancer Institute, Portland, OR
Poster Number: TPS1119
Date/Time: Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

Pembrolizumab, Maveropepimut-S and Low Dose Cyclophosphamide in Advanced Epithelial Ovarian Cancer –Results from Phase 1 and Expansion Cohort of PESCO Trial

Presenter: Ana Veneziani, M.D., Ph.D., Clinical Research Fellow at the Princess Margaret Cancer Centre, Toronto, ON
Poster Number: 5505
Date/Time: Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

The presentations will be available on the IMV website under the Scientific Publications & Posters section following the meeting.

Oncternal Therapeutics to Provide Business Update and Report First Quarter 2022 Financial Results

On April 28, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it will report first quarter 2022 financial results after the U.S. financial markets close on Thursday, May 5, 2022 (Press release, Oncternal Therapeutics, APR 28, 2022, View Source [SID1234613145]). Oncternal’s management will host a webcast at 2:00 p.m. PT (5:00 p.m. ET) to provide a comprehensive business update and discuss the Company’s financial results.

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The live webcast of the call will be available online at investor.oncternal.com and the call will be archived there for at least 30 days.