On August 3, 2023 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three and six months ended June 30, 2023 (Press release, Opko Health, AUG 3, 2023, View Source [SID1234633765]).

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Second quarter business highlights included the following:

U.S. FDA approved NGENLA for pediatric growth hormone deficiency; OPKO earned a $90 million milestone payment from its commercial partner, Pfizer. In June 2023, the U.S. Food and Drug Administration (FDA) approved NGENLA (somatrogon), a once-weekly, human growth hormone analog indicated for the treatment of pediatric patients aged three years and older with impaired growth due to insufficient growth hormone. Pfizer, OPKO’s commercial partner, expects NGENLA to become available for U.S. prescribing this month. In addition to the $90 million milestone payment earned upon receipt of FDA approval, OPKO is entitled to profit sharing based on regional, tiered gross profit for both NGENLA and Genotropin, Pfizer’s daily human growth hormone.
NGENLA has now been approved in 44 markets including the U.S., Japan, EU Member States, Canada and Australia; sales are underway by Pfizer in over 18 countries with expectations to launch in all priority international markets by year-end. NGENLA is the first once-weekly product approved for the treatment of pediatric growth hormone deficiency in Japan, Canada, Australia, the United Kingdom, Taiwan, United Arab Emirates and Brazil. OPKO is entitled to gross profit sharing in all global markets based on regional, tiered gross profit for both NGENLA and Genotropin, with the U.S. region commencing gross profit sharing in August 2023.
OPKO Health’s ModeX Therapeutics, Inc. (ModeX) advanced its antiviral and immune-oncology product pipeline. ModeX continued to advance its pipeline of antiviral and immune-oncology programs utilizing its next-generation multispecific antibodies, and anticipates initiating a Phase 1 clinical trial for certain cancers next year. In addition, ModeX’s collaboration with Merck to develop MDX-2201, its vaccine for Epstein-Barr virus, is progressing. As part of its ongoing business strategy, ModeX is pursuing additional licensing and collaboration opportunities with strategic partners for certain other pipeline candidates.

BioReference Health continued on its path to profitability with cost reductions, improved operational efficiencies and enhanced productivity. BioReference continued to implement initiatives to reduce costs and rationalize its business in line with current testing volumes. Additionally, BioReference is focused on improving productivity and enhancing innovation of its higher value specialty testing segments. Other efforts to return this business to profitability include expanding into new market segments, such as providing information for the pharmaceutical market.
Second Quarter Financial Results

Pharmaceuticals: Revenue from products in the second quarter of 2023 increased to $43.5 million from $35.9 million in the second quarter of 2022, driven by sales in OPKO’s international operating companies and an increase in sales of Rayaldee to $7.7 million from $6.2 million in the prior-year period. Revenue from the transfer of intellectual property was $94.9 million in the second quarter of 2023, reflecting revenue of $90.0 million triggered by the FDA approval of NGENLA, compared with $87.2 million in the 2022 period, which included an $85.0 million milestone payment related to the commencement of NGENLA sales in Europe and Japan. Total costs and expenses were $74.7 million in the second quarter of 2023, up from $67.7 million in the prior-year period. The increase was mainly due to an increase in cost of revenue and a full quarter of research expenses at ModeX, which was acquired in May 2022. Operating income was $63.6 million in the second quarter of 2023, compared with $55.4 million in the second quarter of 2022.

Diagnostics: Revenue from services in the second quarter of 2023 was $127.0 million compared with $186.8 million in the prior-year period. Revenue decreased due to lower COVID-19 testing volume and reimbursement. BioReference processed approximately 33,000 COVID-19 PCR tests in the second quarter of 2023, representing 1.5% of total testing volume, versus 874,000 tests in the second quarter of 2022, representing 31% of total testing volume. Furthermore, revenue during the 2022 period included $12.1 million from GeneDx, which was sold in April 2022. Total costs and expenses were $171.3 million in the second quarter of 2023 compared with $244.3 million in the second quarter of 2022, resulting in an operating loss of $44.3 million compared with an operating loss of $57.5 million in the 2022 period. The 2022 period included a $15.4 million gain on the sale of GeneDx offset by $5.8 million of operating losses prior to closing in April 2022. BioReference continues to implement cost-reduction initiatives as it works toward profitability.

Consolidated: Consolidated total revenues for the second quarter of 2023 were $265.4 million compared with $309.9 million for the comparable period of 2022. Operating income for the second quarter of 2023 was $7.0 million compared with an operating loss of $10.7 million for the 2022 quarter. Net loss for the second quarter of 2023 included a mark-to-market adjustment of $19.9 million compared to $71.2 million in the 2022 period related to the decrease in share price of GeneDx, resulting in a net loss of $19.6 million, or $0.03 per share, compared with a net loss of $101.7 million, or $0.14 per share, for the 2022 quarter.

Cash and cash equivalents: Cash and cash equivalents were $108.1 million as of June 30, 2023, which does not include the $90.0 million milestone payment from Pfizer that is expected to be received in August 2023.
Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss second quarter financial results, provide financial guidance and answer questions during a conference call and audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until August 10, 2023 by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 7009686. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

On August 3, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the receipt of a Study May Proceed letter from the U.S. Food and Drug Administration (FDA), for a Phase 1/2 dose escalation study of ONCT-534, a novel dual-action androgen receptor inhibitor (DAARI), in patients with metastatic castration-resistant prostate cancer (mCRPC) who have relapsed or are refractory to approved androgen receptor signaling inhibitors (ARSIs) (Press release, Oncternal Therapeutics, AUG 3, 2023, View Source [SID1234633764]). The letter was received prior to the 30-day review date.

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"We are very pleased with the FDA’s authorization to proceed with our Phase 1/2 clinical trial of ONCT-534," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Many men suffering from prostate cancer that has relapsed or is refractory after treatment with standard of care ARSI therapy, such as enzalutamide or abiraterone, need additional treatment alternatives. We believe that ONCT-534’s novel mechanism of action may help address key tumor escape mechanisms that cause such resistance. Preclinical studies suggest that ONCT-534 binds to both the ligand-binding domain (LBD) and N-terminal domain of the androgen receptor (AR), inhibiting AR function and triggering AR protein degradation, even in the presence of ligand-binding domain alterations including mutations and splice variants such as AR-V7. Clinical sites that will conduct the initial dose finding study for ONCT-534 have been selected and we expect to report preliminary data in the first half of 2024".

On August 3, 2023 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported its participation at an upcoming investor conference (Press release, Nkarta, AUG 3, 2023, View Source [SID1234633762]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Canaccord Genuity 43RD Annual Growth Conference
August 10, 2023
12:00 p.m. ET – fireside chat

A simultaneous webcast of each event will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately 90 days.

On August 3, 2023 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases reported a business update and provided second quarter 2023 financial results (Press release, NextCure, AUG 3, 2023, View Source [SID1234633761]).

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"As we enter the remainder of 2023, we continue generating important data and are nearing updates on our clinical programs expected in the fourth quarter of this year," said Michael Richman, NextCure’s president and chief executive officer. "We expect to continue to advance our programs while prudently managing our resources to support our financial runway into mid-2025."

Q2 2023 Business Highlights and Near-Term Milestones

NC410 (LAIR-2 fusion)

● Continued enrollment in the Phase 1b/2 clinical trial evaluating NC410 in combination with pembrolizumab in patients with immune checkpoint naive or checkpoint refractory solid tumors.
● Phase 1b data are expected in the fourth quarter of 2023.

NC762 (B7-H4 mAb)

● Continued enrollment in the Phase 1b dose expansion study in patients with solid tumors and high expression of B7-H4.
● Phase 1b update is expected in the fourth quarter of 2023.

NC525 (LAIR-1 mAb)

● Continued enrollment in the Phase 1 monotherapy dose escalation and safety study evaluating NC525 in AML patients.
● Phase 1a update is expected in the fourth quarter of 2023.

NC318 (Siglec-15)

● Yale Cancer Center to present in September, "NC318, an Anti-Siglec-15 Humanized mAb, Alone and in Combination with Pembrolizumab in Immunotherapy Pretreated NSCLC", at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.

Financial Guidance

● NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into mid-2025.

Financial Results for Quarter Ended June 30, 2023

● Cash, cash equivalents, and marketable securities as of June 30, 2023, were $130.6 million as compared to $159.9 million as of December 31, 2022. The decrease of $29.3 million was primarily related to cash used to fund operations, and cash used to purchase fixed assets.
● Research and development expenses were $13.4 million for the quarter ended June 30, 2023, as compared to $12.8 million for the quarter ended June 30, 2022. The increase of $0.6 million was primarily related to higher clinical costs.
● General and administrative expenses were $5.7 million for the quarter ended June 30, 2023, as compared to $5.3 million for the quarter ended June 30, 2022. The increase of $0.4 million was primarily related to higher payroll and legal costs partially offset by lower stock compensation costs and lower insurance costs.
● Net loss was $17.9 million for the quarter ended June 30, 2023, as compared with a net loss of $17.9 million for the quarter ended June 30, 2022. Higher research and development expenses and higher general and administrative expenses were offset by higher other income, primarily interest income.

On August 3, 2023 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the second quarter ended June 30, 2023 (Press release, NanoString Technologies, AUG 3, 2023, View Source [SID1234633759]).

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"Strong growth in our spatial biology business and continued durability in our nCounter business helped us generate record revenue during the second quarter," said Brad Gray, President and CEO of NanoString. "We expect to continue to benefit from substantial CosMx instrument order backlog through the back half of the year and into 2024, providing visibility into revenue growth and anticipated reductions in our working capital requirements, cash burn and operating loss."

Second Quarter Financial Highlights

•Total revenue of $44.2 million
•Spatial biology revenue of $23.3 million
•nCounter revenue, inclusive of all service and other revenue, of $20.9 million
•Cash, cash equivalents and short-term investments balance of $117.6 million as of June 30, 2023
Spatial Biology
•Accelerated CosMx shipments during Q2, resulting in Q2 spatial biology instrument revenue growth of 188% year-over-year
•Successfully defended substantial CosMx instrument order book, fulfilling or retaining approximately 97% of cumulative orders as of June 30, 2023
•Captured new orders for spatial biology instruments at a rate exceeding the Q1 pace, and retained more than $35 million in CosMx instrument order backlog as of June 30, 2023
•Recorded spatial biology consumables revenue growth of 44% year-over-year, and approximately $85,000 of annualized pull-through, driven by a steady GeoMx consumables pull-through over a larger installed base supplemented by growing shipments of CosMx consumables
•Partnered with Owkin and world-leading cancer research institutions and announced the launch of Multi Omic Spatial Atlas in Cancer (MOSAIC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s annual meeting. MOSAIC is a project designed to revolutionize cancer research and unlock potential new breakthrough treatments through the use of spatial omics, which can leverage AI to help reveal the location and molecular activity of tumor and immune cells by providing a spatial atlas of cancer cells
•Partnered with Acrobat Genomics and the Illumina Accelerator to collaborate with Stanford Medicine to discover new drug targets for gene editing-based therapeutics using GeoMx Digital Spatial Profiler (DSP) technology
•Grew total spatial biology system installed base to approximately 445 systems, an increase of approximately 41% year-over-year
•Total peer-reviewed publications featuring our spatial biology platforms were approximately 280 as of June 30, 2023, representing an increase of approximately 150 publications in the last 12 months
nCounter
•Recorded nCounter consumables revenue growth of approximately 8% year-over-year and approximately $46,000 of annualized pull-through
•Total installed base of our nCounter platforms of approximately 1,135, an increase of approximately 5% year-over-year
•Total peer-reviewed publications featuring nCounter were approximately 7,075 as of June 30, 2023, representing an increase of approximately 1,275 publications in the last 12 months
Guidance
Management reiterated its full year guidance, which remains as follows:
•Total revenue of $175 to $185 million
◦Spatial biology revenue of $100 to $105 million
◦nCounter revenue, inclusive of all service and other revenue, of $75 to $80 million
•Adjusted EBITDA loss of $65 to $75 million

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 June 30,
GAAP Non-GAAP
2023 2022 2023 2022
Revenue $ 44,157 $ 32,219 $ 44,157 $ 32,219
Cost of revenue 29,757 15,852 27,168 14,756
Gross margin 33 % 51 % 38 % 54 %
Research and development 18,214 17,346 14,428 14,474
Selling, general and administrative 39,076 36,112 29,260 30,224
Adjusted EBITDA N / A N / A $ (26,699) $ (27,235)
Non-operating expense, net (778) (2,148) (778) (2,148)
Net loss $ (43,668) $ (39,239) $ (27,477) $ (29,383)

Six Months Ended June 30,
GAAP Non-GAAP
2023 2022 2023 2022
Revenue $ 79,962 $ 63,299 $ 79,962 $ 63,299
Cost of revenue 52,628 30,630 47,720 28,545
Gross margin 34 % 52 % 40 % 55 %
Research and development 34,332 34,763 27,083 29,430
Selling, general and administrative 76,442 72,467 59,022 59,621
Adjusted EBITDA N / A N / A $ (53,863) $ (54,297)
Non-operating expense, net (1,466) (4,178) (1,466) (4,178)
Net loss $ (84,906) $ (78,739) $ (55,329) $ (58,475)

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 second quarter of 2023 and the six months ended June 30, 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 Following registration, 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 August 3, 2023 at 7:30pm ET through midnight ET on August 17, 2023. To access the replay, dial (800) 770-2030 or (647) 362-9199 and reference Conference ID: 72369. The webcast will also be available on our website for one year following the completion of the call.