On November 4, 2024 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported financial results for the quarter that ended September 30, 2024 (Press release, Tempus, NOV 4, 2024, View Source [SID1234647681]). The company also announced that it has entered into an agreement to acquire Ambry Genetics, a leader in genetic testing that aims to improve health by understanding the relationship between genetics and disease.

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Revenue increased 33.0% year-over-year to $180.9 million in the third quarter of 2024
Data and services revenue growth accelerated to 64.4% year-over-year
Genomics unit growth accelerated to 23.9% annually with rising average revenue per clinical test
Net Loss of $(75.8 million), which included $22.2 million of stock compensation expense and related employer payroll taxes
Adjusted EBITDA improved $14.4 million year over year to $(21.8 million)
Expect full year 2024 revenue of ~$700 million, which represents ~32% annual growth
For additional information on the quarter, including a letter from our CEO and CFO, please visit our investors relations site at investors.tempus.com.

"The overall business performed well in the quarter, as demonstrated by accelerating volume growth in our genomics business and accelerating revenue growth in our data and services business, specifically within Insights," said Eric Lefkofsky, Founder and CEO of Tempus. "We’re also excited to announce the pending acquisition of Ambry Genetics, which broadens our testing portfolio, expands our disease coverage, and enhances the types of products we can offer to our biotech and pharmaceutical partners. In addition, Ambry is uniquely positioned given that its revenues are currently growing at north of 25% a year and it generates meaningful EBITDA and cash flow."Genomics revenue of $116.4 million in the third quarter of 2024, an increase of $19.6 million or 20.3% over the third quarter of 2023, with 23.9% unit growth.
Data and services revenue of $64.5 million in the third quarter of 2024, an increase of $25.3 million or 64.4% over the third quarter of 2023.
Non-GAAP Genomics gross margin was 49.3% in the third quarter of 2024, compared to 51.9% in the third quarter of 2023, largely related to one-time cash payments in 2023.

Non-GAAP Data and services gross margin was 78.3% in the third quarter of 2024, compared to 60.5% in the third quarter of 2023, led by Insights, or data licensing revenue, which grew 86.6% year over year.
Net Loss of $(75.8 million), which included $22.2 million of stock compensation and related employer payroll taxes compared to net loss of $(552.2 million) in the second quarter of 2024, including $493.1 million of stock compensation and related employer taxes and net loss of $(53.4 million) in the third quarter of 2023.
Adjusted EBITDA $(21.8 million) in the third quarter of 2024, compared to $(31.2 million) in the second quarter of 2024, and $(36.2 million) in the third quarter of 2023.
Ending cash and marketable securities were $466.3 million.
Additional Operating Highlights

Announced a multi-year first of its kind collaboration with BioNTech to leverage Tempus’ TCR dataset in support of BioNTech’s next-generation oncology pipeline.
Announced a 3 year extension with Merck EMD at the culmination of our last 3 year strategic agreement.
Initiated a collaboration with OneOncology to bring more biomarker-driven trials to patients in the community setting at scale.
Initiated the beta launch of our patient-facing app, Olivia, an AI-enabled personal health locker that empowers individuals to holistically organize, store, and manage their own health data through our generative AI healthcare concierge.

Ambry Genetics Acquisition

Tempus reported that it has entered into an agreement to acquire Ambry Genetics, a leader in genetic testing. Under the terms of the agreement, Tempus will pay $375 million in cash and $225 million in shares at closing, of which $100 million will be subject to a lock-up agreement until one year post-transaction close. The deal is expected to be financed in part through a $300 million increase in short and long term debt provided by Ares, Tempus’ current lender. Ambry expects to generate >$300 million in revenue in calendar year 2024 and EBITDA of >$40 million. For more information on Ambry and its impact, see Tempus’ latest investor deck.

Ambry is a leader in hereditary cancer screening and currently serves as Tempus’ main reference lab in this category. The acquisition will provide Tempus with expanded testing capabilities for inherited cancer risk. These services are becoming more and more important for healthcare professionals navigating critical medical decisions with cancer patients and their relatives.

In addition to expanding and enhancing the company’s hereditary screening portfolio, the acquisition of Ambry will complement Tempus’ strategy of using data to advance clinical and scientific innovation. Ambry’s extensive product offerings will also allow Tempus to expand into new disease categories, including pediatrics, rare disease, immunology, women’s reproductive health, and cardiology.

Financial Outlook and Guidance

Tempus continues to expect full year 2024 revenue of approximately $700 million, which represents approximately 32% year-over-year growth and approximately $(105 million) in adjusted EBITDA, an improvement of approximately $50 million over 2023.

Webcast and Conference Call Information

A conference call and webcast will begin today, November 4, 2024 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 7177136
Domestic Dial-in Number: (800) 715-9871
International Dial-in Number: (646) 307-1963
Live Webcast: View Source

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

On November 4, 2024 AbCellera (Nasdaq: ABCL) reported financial results for the third quarter of 2024 (Press release, AbCellera, NOV 4, 2024, View Source [SID1234647680]). All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"Through the third quarter we continued to execute on our key priorities of advancing our internal pipeline and building capabilities to support clinical trials activities in 2025 and beyond," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "Notably, we completed the consolidation into our new headquarters in Vancouver, Canada, which marks a significant milestone towards completing our platform and infrastructure investments."

Q3 2024 Business Summary

Expanded existing collaboration with Eli Lilly and Company to discover therapeutic antibodies for programs in immunology, cardiovascular disease, and neuroscience.
Reported the start of two additional partner-initiated programs with downstreams to reach a cumulative total of 95 partner-initiated program starts with downstreams.
Maintained a cumulative total of 14 molecules advanced to the clinic.
Key Business Metrics

Cumulative Metrics

September 30, 2023

September 30, 2024

Change %

Partner-initiated program starts with downstreams

84

95

13%

Molecules in the clinic

10

14

40%

AbCellera started discovery on an additional two partner-initiated programs with downstreams to reach a cumulative total of 95 partner-initiated program starts with downstreams in Q3 2024 (up from 84 on September 30, 2023). AbCellera’s partners have advanced a cumulative total of 14 molecules into the clinic (up from 10 on September 30, 2023).

Discussion of Q3 2024 Financial Results

Revenue – Total revenue was $6.5 million, compared to $6.6 million in Q3 2023. In both periods, the majority of revenues were research fees generated by our partnerships.
Research & Development (R&D) Expenses – R&D expenses were $41.0 million, compared to $37.9 million in Q3 2023, reflecting underlying continued growth in program execution, platform development, and investments in internal programs.
Sales & Marketing (S&M) Expenses – S&M expenses were $3.1 million, compared to $3.5 million in Q3 2023.
General & Administrative (G&A) Expenses – G&A expenses were $19.1 million, compared to $14.4 million in Q3 2023.
Net Loss – Net loss of $51.1 million, or $(0.17) per share on a basic and diluted basis, compared to net loss of $28.6 million, or $(0.10) per share on a basic and diluted basis in Q3 2023.
Liquidity – $670.4 million of total cash, cash equivalents, and marketable securities and with approximately $205 million in available non-dilutive government funding to execute on AbCellera’s strategy, bringing total available liquidity to over $875 million.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

On November 4, 2024 Lomond Therapeutics, Inc., a clinical-stage biotechnology company dedicated to discovering and developing potentially best-in-class and first-in-class medicines for the treatment of hematological malignancies, reported the completion of a reverse merger transaction with Venetian-1 Acquisition Corp. and the closing of a $44 million private placement financing (Press release, Lomond Therapeutics, NOV 4, 2024, View Source [SID1234647679]). Following the reverse merger, Venetian-1 Acquisition Corp. changed its name to Lomond Therapeutics Holdings, Inc. ("Lomond Therapeutics" or the "Company"), and will continue the historic and innovative business of Lomond Therapeutics, Inc.

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"This transaction provides the resources necessary to advance our potentially best-in-class programs, lomonitinib, lonitoclax and our menin inhibitor, through clinical development," said Iain Dukes, M.A. D.Phil., co-founder and chief executive officer at Lomond Therapeutics. "Lomonitinib is currently being evaluated in a Phase 1b clinical trial in patients with mutated FLT3 relapsed refractory AML – an area of important unmet need and will shortly commence recruitment of CLL and selected lymphoma patients to evaluate lonitoclax, a potentially first-in-class oral targeted selective B-cell lymphoma-2 ("BCL-2-2") inhibitor."

The Company announced that current investors, OrbiMed and Torrey Pines Investment have participated in the placement alongside new investors led by Deerfield Management Company, American Financial Group, Heights Capital and others.

Previous members of Lomond Therapeutics, Inc.’s board of directors, Carl L. Gordon Ph.D., CFA, Iain Dukes M.A., D.Phil., Nikolay Savchuk Ph.D., and Eddie Wang Rodriguez J.D., will continue as directors of the Company.

The offering was exempt from registration under Section 4(a)(2) of the United States Securities Act of 1933, as amended, and Rule 506 of Regulation D promulgated by the U.S. Securities and Exchange Commission ("SEC") thereunder. The Common Stock in the offering was sold to "accredited investors," as defined in Regulation D, and was conducted on a "reasonable best efforts" basis.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Raymond James and Wedbush & Co. acted as the placement agents and Venetian-1 Acquisition Corp. was formed by Montrose Capital, which sponsored the transaction.

On November 4, 2024 Shasqi, Inc. ("Shasqi") a biotech company using in-vivo click chemistry to enable pre-targeting for ADCs and radioisotopes, reported that Founder and CEO, José M. Mejía Oneto, MD, PhD, and VP of Research, Travis Biechele, PhD will both be presenting sessions at the 15th World ADC San Diego conference taking place in San Diego, between November 4-7th (Press release, Shasqi, NOV 4, 2024, View Source [SID1234647678]).

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Shasqi will also be presenting posters at the World ADC conference, as well as at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting taking place in Houston, between November 8-10th.

The presentations and posters will share data from Shasqi’s novel Click Activated Protodrugs Against Cancer (CAPAC) technology, a pre-targeting approach using in-vivo click chemistry to enable preferential drug exposure in tumors versus normal tissues. This can be used to improve the therapeutic index of potent cytotoxic drugs or radioisotopes.

"99% of the ADC dose is catabolically eliminated in normal tissues leading to active payload exposure and toxicity. I am eager to discuss what we can do as a field to reduce some of the target-independent toxicities seen with the ADC platform. Shasqi’s pre-targeting approach is a potential solution to reduce payload exposure and toxicity to normal cells that applies to any payload including those from ADCs or targeted radiopharma approaches. I am excited to share data from our platform at World ADC," said VP of Research, Travis Biechele, PhD.

Shasqi is seeking to establish new and advance existing conversations with partners around the applications of their CAPAC pre-targeting technology at both World ADC and SITC (Free SITC Whitepaper).

Details on each of the sessions can be found below.

World ADC speaking session – November 4th at 10:30am PDT
Presenter: Travis Biechele, PhD.
5th Toxicity Day track
Title: Understanding the drivers of target independent toxicities associated with ADCs and solutions to overcome them

World ADC speaking session – November 6th at 12:45pm PDT
Presenter: José M. Mejía Oneto, MD, PhD.
Discovery Chemistry track
Title: Click chemistry enabled pre-targeting as a solution to target-independent ADC toxicities

World ADC Poster session – November 5th at 6:30pm PDT
Poster 1 title: Pre-targeting with in vivo click chemistry enables preferential drug exposure in tumors versus normal tissues
Poster 2 title: CEACAM5 is an ideal target for click chemistry enabled pre-targeting

SITC 39th Annual Meeting – November 9th at 9:00am CDT
Poster title: Doxorubicin-based click chemistry therapeutic activates potent cytotoxic immune responses in advanced sarcoma patients in a Phase 1/2a clinical trial
Poster Number: 624

Poster title: Attenuated MMAE therapeutic activated by click chemistry at the tumor evokes potent immune responses
Poster Number: 1278

On November 4, 2024 SimBioSys, a pioneering TechBio company at the forefront of digital precision medicine for cancer care, reported its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons across the US (Press release, SimBioSys, NOV 4, 2024, View Source [SID1234647677]). The updated TumorSight Viz now processes images with AI in a matter of minutes, integrates enhanced AI-driven tumor segmentation, enables seamless access to MRI images through direct connectivity to PACS systems, and has a first of its kind clinical decision support (CDS) feature that informs providers of evidence-based treatment options. The addition of the CDS application is designed to enhance treatment planning and optimize oncologists’ decisions for early-stage breast cancer patients’ surgery.

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With the recent FDA mandate which now requires breast density reporting for all women undergoing a mammogram, the demand for MRI as a supplementary screening tool is anticipated to rise. TumorSight Viz offers healthcare providers a powerful platform to visualize MRI data in 3D, supporting breast surgeons in tailoring treatment decisions to each patient’s unique tumor characteristics. The platform’s new CDS tool is designed to empower providers with advanced imaging insights and best practices for breast-conserving surgeries, aligning with updated NCCN guidelines promoting minimally invasive approaches when feasible and desired by patients.

"TumorSight Viz’s clinical decision support functionality provides a groundbreaking resource to assist breast surgeons and oncologists in considering the best possible approaches for each patient, fostering shared decision-making and precision care," said Dr. Freya Schnabel from NYU.

TumorSight Viz: Key Enhancements

Enhanced AI-Driven Segmentation: Utilizing AI, TumorSight Viz is designed to deliver accurate and efficient tumor and tissue segmentation, enabling detailed 3D spatial visualization to support treatment planning.
Clinical Decision Support (CDS) Application: The new CDS application is designed to provide data-driven insights for informing breast surgeons’ planning and preparation for surgery
Direct MRI Access via PACS Systems: TumorSight Viz now supports integration with middleware software as well as direct to PACS systems, allowing automated access to MRI images for analysis within the TumorSight platform and seamless fit into the clinician workflow.
Recent NCCN guideline updates emphasize the importance of individualized, data-supported treatment planning to support breast reconstruction and oncoplastic surgery as safe and effective options for eligible patients. TumorSight Viz aligns with these recommendations by enabling volume and anatomical measurements that assist surgeons in utilizing volume displacement techniques with a goal to achieve optimal cosmetic and functional outcomes. With the new CDS capability, surgeons are now better equipped with output measurements from TumorSight Viz that are aligned with standard of care guidelines to help plan lumpectomies more precisely, supporting both effective tumor removal and preservation of breast appearance.

A Game-Changer in Breast Cancer Care

Breast cancer affects more than 300,000 patients in the U.S. annually, many of whom now stand to benefit from SimBioSys’s enhanced TumorSight platform. By combining advanced AI-driven visualizations with CDS tools, TumorSight Viz is designed to provide surgeons, together with their patients, greater confidence in their treatment decisions.

"This second FDA clearance represents a significant milestone in our mission to redefine precision medicine for cancer," said Barry Rosen, MD, Chief Medical Officer at SimBioSys. "TumorSight Viz’s latest capabilities elevate the standard of breast cancer care by allowing surgeons to make more informed choices, moving closer to an era of precision surgery that reduces variation and supports breast conservation when desired by the patient."

TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer.

About TumorSight Viz:
TumorSight Viz provides clinicians with 3D spatial visualizations of breast cancer using standard-of-care medical imaging (DCE MRI). Clear 3D "digital twin" renderings automatically display the tumor in the context of auto-segmented anatomical structures and provide key metrics used to inform the treatment planning process in conjunction with patient history and standard of care testing. TumorSight Viz received its original 510(k) FDA clearance in December 2023. Learn more about TumorSight Viz at View Source