On May 9, 2023 Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the first quarter ended March 31, 2023 (Press release, Nektar Therapeutics, MAY 9, 2023, View Source [SID1234631283]).

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Cash and investments in marketable securities at March 31, 2023, were $456.8 million as compared to $505.0 million at December 31, 2022. Nektar’s cash and marketable securities are expected to support strategic development activities and operations into at least the middle of 2026.

"With Nektar regaining full rights to rezpegaldesleukin, we are already making progress towards initiating a Phase 2b study in atopic dermatitis," said Howard W. Robin, President and CEO of Nektar. "We are confident that our focus on immunology is the best path forward to bring important potential therapies to patients and create shareholder value. Based on feedback from key opinion leaders in atopic dermatitis, we are enthusiastic about the future prospects for rezpegaldesleukin in a significant and growing biologic treatment landscape. Finally, we are working diligently to advance our immunology research pipeline with the goal of advancing a new IND candidate next year."

Summary of Financial Results

Revenue in the first quarter of 2023 was $21.6 million as compared to $24.8 million in the first quarter of 2022.

Total operating costs and expenses in the first quarter of 2023 were $156.3 million as compared to $141.4 million in the first quarter of 2022. Operating costs and expenses for the first quarter include $76.5 million in non-cash goodwill impairment, $13.2 million in other non-cash impairment charges primarily related to lease assets, and $8.0 million in other restructuring costs, offset by decreases in R&D and G&A expenses.

R&D expense in the first quarter of 2023 was $30.5 million as compared to $107.3 million for the first quarter of 2022. R&D expense decreased primarily due to the wind down of the bempegaldesleukin program.

G&A expense was $21.1 million in the first quarter of 2023 as compared to $27.3 million in the first quarter of 2022. G&A expense decreased primarily due to the wind down of the bempegaldesleukin program.

Restructuring, impairment and costs of the terminated program were $21.2 million in the first quarter of 2023 as compared to $1.5 million in the first quarter of 2022. The amount for the first quarter of 2023 includes $13.2 million in non-cash lease and equipment impairment charges, $5.5 million in severance, and $2.5 million in other costs.

Net loss for the first quarter of 2023 was $137.0 million or $0.73 basic and diluted loss per share as compared to a net loss of $90.4 million or $0.49 basic and diluted loss per share in the first quarter of 2022. Excluding the $89.7 million in non-cash goodwill and other impairment charges, net loss, on a non-GAAP basis, for the first quarter of 2023 was $47.3 million or $0.25 basic and diluted loss per share.

First Quarter 2023 and Recent Business Updates

● On April 27, 2023, Nektar announced that it will be regaining the full rights to rezpegaldesleukin from Eli Lilly and Company. Nektar plans to move forward with rezpegaldesleukin and will initiate a Phase 2b study in patients with moderate-to-severe atopic dermatitis in 2023. The company will also explore other auto-immune indications for the development plan for rezpegaldesleukin.

● On April 17, 2023, Nektar announced a strategic reprioritization and cost restructuring plan that includes a new pipeline focus on immunology, as well as several cost reduction initiatives.

Conference Call to Discuss First Quarter 2023 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, May 9, 2023.

The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through June 4, 2023.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

On May 9, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in therapeutic monoclonal antibody space, reported that the Company has been selected for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting held in Chicago on June 2-6, 2023 (Press release, Nascent Biotech, MAY 9, 2023, View Source [SID1234631282]). The poster presentation, entitled "Phase I Study of Pritumumab in Brain Cancer", will take place from 1:15-4:15 PM CDT on June 3rd, during the "Central Nervous Systems Tumors" session in Hall A of McCormick Place Convention Center. ASCO (Free ASCO Whitepaper) is the largest clinical oncology conference that brings together cancer leaders from across the globe to discuss the latest cutting-edge research.

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The Company will have a clinical trials medical team member presenting the pivotal results from the NAS-101 trial, and interested parties are welcome to stop by the poster (board #410). The poster will also be available for download after the conference by contacting [email protected].

Nascent Biotech therapeutic antibody Pritumumab (PTB) is a natural human antibody originally isolated from lymph nodes of a patient with cervical cancer. This monoclonal antibody targets cell surface Vimentin (also referred to as ectodomain vimentin), shown to be significantly expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy that binds the tumor and recruits the host immune system to eliminate cancer cells.

On May 9, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported financial results for the first quarter 2023 along with recent pipeline and corporate updates (Press release, Mirati, MAY 9, 2023, View Source [SID1234631281]).

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"Today we are pleased to share the significant progress made during the first quarter of 2023, highlighted by our first full quarter of sales for KRAZATI, which we believe is the best-in-class KRASG12C inhibitor. This is just the beginning of our journey with KRAZATI, as we continue to advance our broad development plan in lung cancer and across other indications and lines of therapy," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "In addition, we advanced our robust portfolio of potential best-in-class clinical programs, including MRTX1133, our KRASG12D inhibitor, MRTX1719, our MTA cooperative PRMT5 inhibitor, MRTX0902, our SOS1 inhibitor and sitravatinib, our TAM receptor inhibitor. Looking ahead, we remain committed to executing on our strategy to advance our pipeline of targeted oncology programs to positively impact the lives of people living with cancer."

Pipeline Updates

Adagrasib (Potent and selective KRASG12C inhibitor)

•The Company presented updated clinical data for adagrasib as a targeted treatment for KRASG12C-mutated advanced pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer and other solid tumors at the April session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series Program. In addition, the Journal of Clinical Oncology published these findings as a Rapid Communication.

•Adagrasib was included as the only KRAS inhibitor in the National Comprehensive Cancer Network guidelines for Central Nervous System Cancers for patients with KRASG12C -mutated non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases and for KRASG12C -mutation positive pancreatic adenocarcinoma cancer patients.

•The Company is on track to complete supplemental New Drug Application (sNDA) for third-line and beyond colorectal cancer by year-end 2023.

•The Company continues to enroll in KRYSTAL-10, a Phase 3 registrational clinical study in second-line colorectal cancer patients, evaluating the combination of adagrasib plus cetuximab versus chemotherapy. The Company expects to complete enrollment by year-end 2023.

•Enrollment ongoing in KRYSTAL-12, a Phase 3 clinical study of adagrasib versus docetaxel in second line NSCLC. The Company plans to share data from this study in 2024.

•The Company plans to share updated first-line NSCLC data of the combination of adagrasib with pembrolizumab and first-line development plans in the second half of 2023.

Sitravatinib (Potent TAM receptor inhibitor)

•The Company remains on track to provide topline final overall survival results from the global, registration-enabling Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC in the second quarter of 2023.

MRTX1133 (Potent and selective KRASG12D inhibitor)

•In March 2023, the Company began enrolling patients in the Phase 1/2 clinical study with plans for multiple expansion cohorts in pancreatic, colorectal, lung and other tumor types with KRASG12D mutations.

MRTX1719 (MTA cooperative PRMT5 inhibitor)

•The Company presented posters to highlight the mechanism by which MRTX1719 elicits potent and selective synthetic lethality in MTAP deleted tumors as well as the further enhancement of antitumor activity via rational targeted combination strategies at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

•Enrollment is ongoing in the Phase 1/2 clinical study to evaluate MRTX1719, an MTA cooperative PRMT5 inhibitor, in patients with solid tumors harboring MTAP-gene deletions with plans to share initial clinical data from this study in the second half of 2023.

MRTX0902 (Potent SOS1 inhibitor)

•The Company presented preclinical data describing the ability of MRTX0902 to enhance anti-tumor activity and overcome acquired resistance in combination with either adagrasib, a potent and selective KRASG12C inhibitor, or an epidermal growth factor receptor inhibitor (e.g. osimertinib) at the 2023 AACR (Free AACR Whitepaper) Annual Meeting.

•The Company continues to enroll in the Phase 1/2 clinical study evaluating MRTX0902, a selective KRAS signal modifying SOS1 inhibitor, in an escalating dose cohort as a monotherapy and expects to initiate dose escalation cohorts combining MRTX0902 and adagrasib in the second half of 2023.

Recent Corporate Updates

•In May 2023, the Company announced a strategic partnership with Sarah Cannon Research Institute aimed at increasing diversity in clinical study recruitment practices.

First Quarter Financial Results

•Cash, cash equivalents and short-term investments of approximately $0.9 billion as of March 31, 2023.

•Net KRAZATI product revenue for the first quarter 2023 was $6.3 million. There was no product revenue for the same period in 2022.

•License and collaboration revenue for the first quarter 2023 was $0.9 million, compared to $0.7 million for the same period in 2022. Both periods represent clinical supply revenue earned under the agreement with Zai Lab.

•Cost of product revenue for the first quarter 2023 was $0.8 million, of which $0.6 million related to product manufacturing and distribution costs, and royalties incurred on net sales of KRAZATI, and
2

$0.2 million represented non-cash amortization expense for our intangible asset. There was no cost of product revenue for the same period in 2022.

•Research and development expenses for the first quarter 2023 were $126.7 million, compared to $131.0 million for the same period in 2022. The decrease in research and development expenses was primarily driven by a reduction in clinical development costs for sitravatinib as enrollment was completed in the SAPPHIRE Phase 3 clinical study in the second quarter of 2022, and lower clinical manufacturing costs to support ongoing clinical studies, partially offset by increases in costs for earlier stage clinical development programs such as MRTX1133, and an increase in salaries and other employee related expense to support portfolio advancement.

•Selling, general and administrative expenses for the first quarter 2023 were $73.5 million, compared to $54.0 million for the same period in 2022. The increase in selling, general and administrative expenses was primarily due to an increase in headcount-related costs, including share-based compensation and salaries, and commercial-related costs to support the marketing and sales of KRAZATI.

•Net loss for the first quarter 2023 was $184.6 million, or $3.18 per share basic and diluted, compared to a net loss of $188.4 million, or $3.40 per share basic and diluted for the same period in 2022.

•Net reduction in cash, cash equivalents and short-term investments for the first quarter was $181.5 million, which included 2022 annual bonus payments and a one-time cash payment of $15 million to Pfizer. The Company expects 2023 net cash burn to annualize within a range of $525 million to $580 million.

Conference Call Information

There will be a conference call on May 9, 2023 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the first quarter and provide corporate updates.

Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 773-305-6853 or international +1 888-394-8218, confirmation code: 8109078.

A replay of the call will be available approximately 2 hours after the event has ended at the same website.

On May 9, 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 a business update and announced financial results for the first quarter ended March 31, 2023 (Press release, Mersana Therapeutics, MAY 9, 2023, View Source [SID1234631280]).

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"We’re excited by the opportunities that lie ahead, with topline data for UPLIFT on the near-term horizon and a comprehensive development plan designed to establish UpRi as a foundational medicine in ovarian cancer," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "Beyond UpRi, we continue to steadfastly focus on ADC innovation as we leverage our proprietary platforms to advance a pipeline of wholly owned assets as well as programs with several collaborators. Thanks to these core strengths and our solid financial position, we believe we have an opportunity to make 2023 a transformational year for Mersana."

Strategic Goals, Recent Developments and Anticipated Milestones

Build UpRi into a Foundational Medicine in Ovarian Cancer

Approaching Topline Data for UPLIFT Registrational Trial: UpRi is a first-in-class NaPi2b-targeting ADC with a novel scaffold-linker-payload that enables high drug-to-antibody ratio and controlled bystander effect.​ Approximately 270 patients with platinum-resistant ovarian cancer were enrolled in UPLIFT. The clinical trial’s primary endpoint is the objective response rate (ORR) in the NaPi2b positive population. The company plans to report topline data from the trial in mid-2023 and, assuming positive data, submit a potential BLA to the U.S. Food and Drug Administration (FDA) for the treatment of patients with platinum-resistant ovarian cancer around the end of 2023.

Progressing Enrollment in UP-NEXT Trial: Patient dosing is ongoing in UP-NEXT, the company’s Phase 3 clinical trial of UpRi as monotherapy maintenance following treatment with platinum doublets in NaPi2b-positive recurrent platinum-sensitive ovarian cancer. If the data from this trial are positive, UP-NEXT could serve as a post-approval confirmatory trial in the United States, support potential approvals outside of the United States and support UpRi’s expansion into earlier lines of therapy.

Advancing Dose Expansion Portion of UPGRADE-A Trial: In the first quarter of 2023, Mersana completed dose escalation and initiated the dose expansion portion of UPGRADE-A, a Phase 1 clinical trial of UpRi in combination with carboplatin. The company expects to present initial interim data from the trial in the second half of 2023.
Build a Pipeline of Highly Impactful Cancer Medicines

Continuing Dose Escalation of XMT-1660 in Phase 1 Trial: XMT-1660 is a B7-H4-directed Dolasynthen ADC designed with a precise, target-optimized drug-to-antibody ratio (DAR 6) and Mersana’s DolaLock microtubule inhibitor payload with controlled bystander effect. The company expects to complete the dose escalation portion of the company’s multicenter Phase 1 clinical trial investigating XMT-1660 in patients with breast, endometrial and ovarian cancers in 2023.

XMT-2056 Phase 1 Trial: XMT-2056 is a systemically administered Immunosynthen STING agonist ADC (DAR 8) that is designed to target a novel HER2 epitope and locally activate STING signaling in both tumor-resident immune cells and in tumor cells. In March 2023, the FDA placed Mersana’s multicenter Phase 1 trial of XMT-2056 on clinical hold following the company’s communication to FDA that it was voluntarily suspending the trial due to a Grade 5 serious adverse event (SAE) that was deemed to be related to XMT-2056. Mersana continues to investigate the SAE and to evaluate next steps related to the development of XMT-2056.
First Quarter 2023 Financial Results

Net cash used in operating activities for the first quarter of 2023 was $29.0 million.

Cash, cash equivalents and marketable securities as of March 31, 2023 were $273.9 million, compared to cash and cash equivalents of $280.7 million as of December 31, 2022. Mersana expects that its available funds will be sufficient to support its operating plan commitments into the second half of 2024.
Collaboration revenue for the first quarter of 2023 was $7.8 million, compared to $2.0 million for the same period in 2022. The year-over-year increase was primarily related to Mersana’s collaboration agreements with Merck KGaA, Darmstadt, Germany and Asana Biosciences.

Research and development (R&D) expenses for the first quarter of 2023 were $47.3 million, compared to $35.8 million for the same period in 2022. Included in first quarter 2023 R&D expenses were $3.3 million in non-cash stock-based compensation expenses. The year-over-year increase in R&D expenses was primarily related to higher manufacturing and clinical costs related to UpRi and an increase in headcount.
General and administrative (G&A) expenses for the first quarter of 2023 were $18.3 million, compared to $12.8 million during the same period in 2022. Included in first quarter 2023 G&A expenses were $3.1 million in non-cash stock-based compensation expenses. The year-over-year increase in G&A expenses was primarily related to increases in medical affairs, pre-commercial activities and headcount.

Net loss for the first quarter of 2023 was $56.2 million, or $0.52 per share, compared to a net loss of $47.3 million, or $0.59 per share, for the same period in 2022.

Conference Call Reminder

Mersana will host a conference call today at 8:00 a.m. ET to discuss business updates and its financial results for the first quarter 2023. To access the call, please dial 877-270-2148 (domestic) or 412-902-6510 (international). A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.

On May 9, 2023 MannKind Corporation (Nasdaq: MNKD) reported financial results for the quarter ended March 31, 2023 (Press release, Mannkind, MAY 9, 2023, View Source [SID1234631279]).

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"Demand for Tyvaso DPI has been very strong, which resulted in $23 million in revenues in the first quarter of 2023," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "I’m excited about our inhaled platform and orphan lung pipeline as we get ready to launch our Phase 2/3 inhaled clofazimine trial for patients in the second half of 2023."

Revenue Highlights

Three Months
Ended March 31,
2023 2022 $ Change % Change
(Dollars in thousands)
Net revenue – Afrezza $ 12,423 $ 9,826 $ 2,597 26 %
Net revenue – V-Go 5,139 — $ 5,139 *
Revenue – collaborations and services 11,386 2,166 $ 9,220 426 %
Royalties – collaborations 11,678 — $ 11,678 *
Total revenues $ 40,626 $ 11,992 $ 28,634 239 %
___________________
* Not meaningful

Afrezza net revenue for the first quarter of 2023 increased compared to the same period in 2022 as a result of higher product demand, higher price (including a more favorable gross-to-net adjustment) and a more favorable cartridge mix. V-Go was acquired in the second quarter of 2022. The increase in collaborations and services revenue reflected that the commercial manufacturing of Tyvaso DPI had not yet commenced in the prior period. Royalties related to Tyvaso DPI, launched in the second quarter of 2022 by United Therapeutics ("UT"), continued to grow based on strong patient demand.

Commercial product gross margin in the first quarter of 2023 was 69% compared to 77% for the same period in 2022 primarily related to the addition of V-Go in the second quarter of 2022 which had a lower gross margin than Afrezza.

Cost of revenue – collaborations and services for the first quarter of 2023 was $10.7 million compared to $8.7 million for the same period in 2022, an increase of $2.0 million, due to an increase in manufacturing activities for Tyvaso DPI.

Research and development expenses for the first quarter of 2023 were $5.6 million compared to $3.5 million for the same period in 2022. The $2.1 million increase was primarily attributed to costs incurred to develop our product pipeline, including MNKD-101 (inhaled clofazimine) and the Afrezza pediatrics clinical study (INHALE-1).

Selling expenses for the first quarter of 2023 were $13.3 million compared to $12.7 million for the same period in 2022. The $0.6 million increase was primarily due to V-Go promotional efforts and increased headcount after the acquisition in the second quarter of 2022 as well as an increase in Afrezza promotional activities, partially offset by the termination of an Afrezza pilot promotional effort targeting primary care physicians which ended in the third quarter of 2022.

General and administrative expenses for the first quarter of 2023 were $10.5 million compared to $7.9 million for the same period in 2022. The $2.6 million increase was primarily attributable to higher stock-based compensation, increased headcount, and higher professional fees.

Interest expense on financing liability was $2.4 million for the first quarter of 2023 and remained consistent with the same period in 2022.

Interest expense on notes was $2.8 million in the first quarter of 2023 and remained consistent with the same period in 2022 due to fixed interest rates and no changes in debt balances.

Cash, cash equivalents and investments as of March 31, 2023 were $166.6 million.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.