On May 3, 2023 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported its financial results for the first quarter ended March 31, 2023 (Press release, NanoString Technologies, MAY 3, 2023, View Source [SID1234630934]).

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"2023 is off to a strong start, with spatial biology revenue up more than 75% over the prior year," said Brad Gray, President and CEO of NanoString. "Demand for our CosMx Spatial Molecular Imager is robust, with new orders driving an increase in CosMx backlog even as we accelerated shipments in the first quarter. We also generated sequential and year-over-year growth in consumable revenue across all our platforms."
First Quarter Financial Highlights
•Total revenue of $35.8 million
•Spatial biology revenue of $17.1 million
•nCounter revenue, inclusive of all service and other revenue, of $18.7 million
•Cash, cash equivalents and short-term investments balance of $154.6 million as of March 31, 2023
Spatial Biology
•Accelerated CosMx shipments during Q1, resulting in Q1 spatial biology instrument revenue growth of 110% year-over-year
•Increased CosMx revenue backlog in Q1, with revenue to be recognized in future periods from cumulative orders received exceeding $40 million
•Grew total spatial biology system installed base to approximately 385 systems, an increase of approximately 31% year-over-year
•Recorded spatial biology consumables revenue growth of 44% year-over-year, with steady GeoMx consumables pull-through over a larger installed base supplemented by growing shipments of CosMx consumables
•Approximately 120 abstracts highlighted at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Nearly 60 spatial abstracts using GeoMx or CosMx, an increase of more than 40% over the prior year
•Total peer-reviewed publications featuring our spatial biology platforms were approximately 232 as of March 31, 2023, representing an increase of approximately 122 publications in the last 12 months
nCounter
•Total installed base of our nCounter platforms of approximately 1,130, an increase of approximately 6% year-over-year
•Total peer-reviewed publications featuring nCounter were approximately 6,820 as of March 31, 2023, representing an increase of approximately 1,570 publications in the last 12 months

2023 Outlook
The company updated its previous financial outlook for 2023, with results now expected as follows:
•Total revenue of $175 to $185 million, as compared to the previous range of $170 to $180 million.
◦Spatial biology revenue of $100 to $105 million, as compared to the previous spatial biology revenue range of $95 to $100 million
◦nCounter revenue, inclusive of all service and other revenue, of $75 to $80 million, unchanged from the previous guidance range
•Adjusted EBITDA loss of $65 to $75 million, unchanged from the previous range
Financial Results
We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the tables at the end of this press release.
(dollars in thousands) Three Months Ended March 31,
GAAP Non-GAAP
2023 2022 2023 2022
Total revenue $ 35,805 $ 31,080 $ 35,805 $ 31,080
Cost of revenue 22,871 14,778 20,552 13,789
Gross margin 36 % 52 % 43 % 56 %
Research and development 16,118 17,417 12,655 14,956
Selling, general and administrative 37,366 36,355 29,762 29,397
Adjusted EBITDA N / A N / A (27,164) (27,062)
Non-operating expense, net (688) (2,030) (688) (2,030)
Net loss $ (41,238) $ (39,500) $ (27,852) $ (29,092)

Supplemental Information

As a supplement to the table above, we have posted to the investor relations section of our website, at View Source, supplemental financial data that include our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the first quarter of 2023 and for each quarter of and the full year of 2022.

Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Investors and other interested parties can register for the call in advance by visiting View Source After registering, an email confirmation will be sent including dial-in details and unique conference call codes for entry. Registration is open throughout the call, but to ensure connection for the full call, registration in advance is recommended. The link to the webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com. A replay of the call will be available beginning May 3, 2023 at 7:30pm ET through midnight ET on May 17, 2023. To access the replay, dial (866) 813-9403 or (929) 458-6194 and reference Conference ID: 573494. The webcast will also be available on our website for one year following the completion of the call.

Non-GAAP, or Adjusted, Financial Information

We believe that the presentation of non-GAAP, or adjusted, financial information provides important supplemental information to management and investors regarding financial and business trends relating to our financial condition and results of operations. Reconciliation of adjusted financial measures to the most directly comparable financial result as determined in accordance with GAAP are included at the end of this press release following the accompanying financial data. A reconciliation of adjusted guidance measures, including Adjusted EBITDA, to corresponding GAAP measures is not available without unreasonable effort due to the uncertainty regarding certain expenses that may be incurred in the future, and we are also unable to predict the probable significance of such adjusted guidance measures. Accordingly, in reliance on the exception provided by Item 10(e)(1)(i)(B) of Regulation S-K, we have not provided a reconciliation for adjusted guidance measures provided in this press release. For further information regarding why we believe that these adjusted measures provide useful information to investors, the specific manner in which management uses these measures and some of the limitations associated with the use of these measures, please refer to "Notes Regarding Non-GAAP Financial Information" at the end of this press release.

On May 3, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that members of management will present at the Bank of America Securities 2023 Healthcare Conference on Wednesday, May 10, 2023 at 12:20 p.m. Eastern Time (Press release, Mersana Therapeutics, MAY 3, 2023, View Source [SID1234630932]).

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A live webcast of this event will be available on the Investors & Media section of Mersana’s website at www.mersana.com. An archived replay will be available for approximately 90 days following the event.

On May 3, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Caroline Litchfield, executive vice president and chief financial officer, is scheduled to participate in a fireside chat at the Bank of America Securities 2023 Healthcare Conference on Wednesday, May 10, 2023, at 8:40 a.m. PDT / 11:40 a.m. EDT (Press release, Merck & Co, MAY 3, 2023, View Source [SID1234630931]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

On May 3, 2023 Magenta Therapeutics, Inc. (Nasdaq: MGTA) ("Magenta") and Dianthus Therapeutics, Inc. ("Dianthus"), a privately-held, clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics, reported that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction (Press release, Magenta Therapeutics, MAY 3, 2023, View Sourcenews-releases/news-release-details/magenta-therapeutics-and-dianthus-therapeutics-announce-merger" target="_blank" title="View Sourcenews-releases/news-release-details/magenta-therapeutics-and-dianthus-therapeutics-announce-merger" rel="nofollow">View Source [SID1234630930]). The combined company will focus on advancing Dianthus’ pipeline of next-generation complement inhibitors, including DNTH103 currently in a Phase 1 clinical trial. Upon completion of the merger, the combined company is expected to operate under the name Dianthus Therapeutics, Inc. and trade on the Nasdaq under the ticker symbol "DNTH".

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In support of the merger, Dianthus has secured commitments for a $70 million private investment in its common stock and pre-funded warrants from a syndicate of healthcare investors led by Fidelity Management & Research Company, Catalio Capital Management, 5AM Ventures, Avidity Partners, Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures and Venrock Healthcare Capital Partners, that is expected to close immediately prior to completion of the merger. With the cash expected from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have approximately $180 million of cash or cash equivalents immediately post-closing. The cash resources are intended to be used to advance Dianthus’ pipeline through multiple clinical data catalysts and is expected to fund operations into mid-2026. The merger and related financing are expected to close in the third quarter of 2023.

"I’m delighted to announce this planned merger with Magenta, which comes at a pivotal moment in the evolution of our company as we advance our pipeline of next-generation complement therapeutics for people living with severe autoimmune diseases," said Marino Garcia, President and Chief Executive Officer of Dianthus Therapeutics. "Gaining access to the public capital markets can enhance our financial strength and fuel our growth strategy, enabling us to unlock the full potential of our pipeline, including our plans to address multiple autoimmune disorders with our clinical-stage active C1s inhibitor, DNTH103."

"After a thorough exploration of our strategic alternatives, management and our Board of Directors believe the transaction with Dianthus Therapeutics will culminate in a successful outcome for our stockholders," said Steve Mahoney, President, Chief Financial and Operating Officer of Magenta. "Dianthus has made rapid progress in developing and advancing DNTH103 into the clinic where it has the potential to be a transformative classical pathway inhibitor for severe autoimmune diseases. We are extremely grateful to our current and former employees who contributed to Magenta’s efforts to develop its programs and we now look forward to the combined company’s advancement on opportunities for value creation for patients."

Magenta previously announced a comprehensive review of strategic alternatives in February 2023 and has since completed winding down a majority of its activities and costs associated with its research and development initiatives, including the termination of its lease and the sale of key assets.

About DNTH103
DNTH103 is an investigational long-acting classical complement pathway inhibitor designed as a less frequent and convenient subcutaneous injection with the potential to treat people living with severe autoimmune diseases. DNTH103, a fully human monoclonal antibody, is designed to selectively target only the active form of the C1s complement protein, inhibiting only the classical complement pathway, with the aim of treating patients with a lower dosing volume as a convenient subcutaneous injection suitable for a self-administered pre-filled pen. Inhibiting the active form of the complement target seeks to address a critical treatment gap in current complement therapies that do not bind selectively to the active protein, wasting a significant amount of the drug on inert proteins. DNTH103 selective inhibition of the classical pathway is engineered to preserve important immune activity of the lectin and alternative complement pathways needed to protect the body against infections from encapsulated bacteria. DNTH103 is also enhanced with YTE half-life extension technology to further reduce dosing frequency.

DNTH103 has a steady cadence of clinical milestones including top-line Phase 1 data aiming to confirm potent classical pathway inhibition and favorable, extended pharmacokinetics expected by the end of 2023, initiation of a Phase 2 trial in generalized Myasthenia Gravis expected in the first quarter of 2024 followed by two additional planned Phase 2 trial initiations in other neuro indications, and planned initiation of an open label proof of efficacy trial in Cold Agglutinin Disease with patient data anticipated in the second half of 2024.

About the Proposed Transaction, Management and Organization
Pre-merger Dianthus stockholders (including Dianthus stockholders issued shares of Dianthus common stock and pre-funded warrants in the concurrent private financing) are expected to own approximately 78.7% of the combined company and pre-merger Magenta stockholders are expected to own approximately 21.3% of the combined company. The percentage of the combined company that Magenta’s stockholders will own as of the close of the transaction is subject to adjustment based on the amount of Magenta’s net cash at the closing date. Immediately prior to the closing of the proposed merger, Magenta stockholders will be issued contingent value rights representing the right to receive certain payments from proceeds received by the combined company, if any, related to pre-transaction legacy assets.

Following the merger, the combined company will be led by Marino Garcia, the current CEO and President of Dianthus Therapeutics, and the current members of the Dianthus management team. Magenta Therapeutics, Inc. will be renamed "Dianthus Therapeutics, Inc." and the corporate headquarters will be co-located in New York, NY and Waltham, MA. The merger agreement provides that the Board of Directors of the combined company will be composed of eight board members, including all six current Dianthus board members and two from Magenta. The transaction has been unanimously approved by the Board of Directors of each company and is expected to close in the third quarter of 2023, subject to customary closing conditions, including, the approvals by the stockholders of each company and other customary closing conditions.

Wedbush PacGrow is serving as lead financial advisor, Houlihan Lokey Financial Advisors is serving as co-financial adviser and Goodwin Procter LLP is serving as legal counsel to Magenta Therapeutics. Jefferies, Evercore ISI, Guggenheim Securities and Raymond James are serving as the placement agents to Dianthus Therapeutics, and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Dianthus Therapeutics.

Webcast Presentation
The companies will host a webcast presentation to discuss the proposed transaction as well as Dianthus’ platform and pipeline assets today, May 3, 2023, at 8:30 a.m. ET. The live webcast can be accessed on the Events & Presentations page of Magenta’s website or by using the participant webcast link. A webcast of the presentation and associated slides will be available on the Investors & Media section of Magenta’s website at View Source and a replay will be archived for one year following the presentation.

On May 3, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported interim data from the Phase 2 portion of the open-label Phase 1/2 study of single-agent eltanexor in patients with higher R/R myelodysplastic neoplasms (Press release, Karyopharm, MAY 3, 2023, View Source [SID1234630928]). The data, featured in a poster presentation at the 17th International Congress on Myelodysplastic Syndromes, showed that eltanexor has promising single-agent efficacy with a generally manageable safety profile.

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As of the February 8, 2023 data cut-off date, 30 patients had been treated with 10mg eltanexor, oral, on Days 1-5 of each week. Eltanexor demonstrated a 27% overall response rate (ORR) in the intent-to-treat (ITT) population and a 31% ORR in the efficacy evaluable population. Median overall survival (mOS) was 8.7 months in both populations. Transfusion independence rate for red blood cells and/or platelets was 29%.

Eltanexor was generally well-tolerated and manageable. The most common adverse events (AEs) were asthenia (47%), diarrhea (43%), and nausea (33%), the majority of which were Grade 1-2. The most common Grade ≥3 treatment-emergent AEs were neutropenia (30%), thrombocytopenia (26.7%), and asthenia (16.7%).

"Existing first-line treatments for higher risk MDS are not typically curative; approximately half of these patients do not respond. Upon progression, median overall survival for these higher risk, relapsed or refractory MDS patients is approximately four to six months. There is a critical need for novel and more effective treatment options for this patient population," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "We are encouraged by the improved overall survival observed to date with eltanexor in this higher risk patient population. These preliminary results are promising and reinforce the potential of XPO1 inhibition to provide meaningful clinical benefit to patients with relapsed/refractory myelodysplastic neoplasms."

Approximately 12,000 to 20,000 people in the United States are diagnosed with MDS each year, with an estimated 87,000 new cases each year worldwide3. HMAs are the current standard of care for newly diagnosed, higher risk MDS patients, who are not candidates for transplant. However, only about 50% of patients respond, with these responses typically lasting less than two years.4 The prognosis of higher risk relapsed/refractory disease is poor, with a median overall survival of four to six months.1,2 There are a limited number of novel agents currently in clinical development for relapsed refractory MDS.

About Eltanexor

Eltanexor (KPT-8602) is an investigational novel SINE compound that functions by binding with, and inhibiting, the nuclear export protein, XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells.

In preclinical models, eltanexor has a broad therapeutic window with minimal penetration of the blood brain barrier and, therefore, has the potential to serve as another SINE compound for cancer indications. Following oral administration, animals treated with eltanexor show lower percentage of body weight loss and improved food consumption than animals similarly treated with selinexor. This allows more frequent dosing of eltanexor, enabling a longer period of exposure than is possible with selinexor.

Eltanexor is an investigational medicine and has not been approved by the United States Food and Drug Administration or any other regulatory agency.