On May 2, 2024 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, reported first quarter financial results for the period ended March 31, 2024 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, MAY 2, 2024, View Source [SID1234642598]).

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"We are very encouraged by the strong start to the OGSIVEO launch and are focused on continuing our momentum towards establishing OGSIVEO as the standard of care treatment for adults with desmoid tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "We are also pleased to have initiated the rolling NDA submission for mirdametinib in children and adults with NF1-PN, which would be our second marketed product serving another group of patients who are currently suffering with a high unmet need, if approved. We are making significant progress across our commercial, development and corporate objectives and look forward to providing updates throughout the year."
Recent Business Highlights and Upcoming Milestones
OGSIVEO (Nirogacestat)
•Strong execution in the first full quarter of launch, with net product revenue of $21.0 million in the first quarter of 2024.
•Received U.S. Food and Drug Administration (FDA) approval of a Supplemental New Drug Application (NDA) for OGSIVEO 150 mg and 100 mg tablets in new blister packaging, which have been developed to enhance patient convenience with OGSIVEO. The blister packs are expected to be on the market in mid-May 2024.
•Received validation from the European Medicines Agency (EMA) on a Marketing Authorization Application (MAA) for nirogacestat for the treatment of adult patients with desmoid tumors in February 2024.
•Additional data from the Phase 3 DeFi trial of nirogacestat in adults with desmoid tumors were accepted for presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. An abstract describing the onset and resolution of ovarian toxicity for desmoid tumor patients treated with nirogacestat was selected as an oral presentation to be delivered on May 31, 2024. Two additional sub-group analyses evaluating nirogacestat in desmoid tumor patients with poor prognostic factors and in those with adenomatous polyposis (APC) mutations will also be presented on June 1, 2024.
•On track to report initial data from the Phase 2 trial evaluating nirogacestat as a monotherapy in patients with recurrent ovarian granulosa cell tumors in the second half of 2024.

•Continuing to support several industry and academic collaborator studies evaluating nirogacestat as part of B-cell maturation antigen (BCMA) combination therapy regimens across treatment lines in patients with multiple myeloma.
Mirdametinib
•Initiated rolling submission of an NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN in March 2024. SpringWorks expects to complete the NDA submission in the second quarter of 2024 and expects to file a MAA with the EMA for mirdametinib for the treatment of children and adults with NF1-PN in the European Union the second half of 2024.
•Data from the pediatric and adult cohorts of the Phase 2b ReNeu trial were accepted for oral presentation as a rapid oral abstract at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting on June 3, 2024. SpringWorks also expects to publish the ReNeu trial results in a peer-reviewed journal in 2024.
Emerging Pipeline
•On track to present additional data from the dose expansion portion of the Phase 1b trial evaluating brimarafenib (BGB-3245) in adult patients with RAF mutant solid tumors in the second half of 2024. Brimarafenib is an investigational, selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene, Ltd.
•Patients continue to be enrolled in the dose escalation phase of the SpringWorks-sponsored Phase 1/2a combination study of brimarafenib and mirdametinib.
•MapKure initiated a Phase 1b combination trial of brimarafenib with panitumumab, a monoclonal antibody targeting Epidermal Growth Factor Receptor in colorectal and pancreatic cancer patients with known MAPK pathway mutations; patient dosing is currently underway.
•Dose expansion in adult patients with NRAS mutant solid tumors is ongoing in the BeiGene-sponsored Phase 1b trial evaluating mirdametinib in combination with BeiGene’s RAF dimer inhibitor, lifirafenib.
•On track to initiate a Phase 1a trial of SW-682, an investigational novel, oral, potent, and selective pan-TEAD inhibitor, in Hippo-mutant solid tumors in the second quarter of 2024.

General Corporate

•The U.S. Patent and Trademark Office has recently issued five new patents for OGSIVEO. The U.S. patent portfolio for OGSIVEO now includes 21 Orange Book listed patents, providing protection into 2043.

First Quarter 2024 Financial Results

•Revenues: OGSIVEO net product revenues were $21.0 million in the first quarter of 2024, the first full quarter of the U.S. launch.
•Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $60.1 million for the first quarter of 2024, compared to $44.2 million for the comparable period of 2023. The increase in SG&A expense was primarily attributable to commercial activities supporting the U.S. launch of OGSIVEO.
•Research and Development (R&D) Expenses: R&D expenses were $53.6 million for the first quarter of 2024, compared to $33.5 million for the comparable period of 2023. The increase in R&D expenses was primarily attributable to an increase in costs related to drug manufacturing, clinical trials, other research, consulting and professional services, and an increase in employee costs associated with headcount growth.
•Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $87.4 million, or $1.18 per share, for the first quarter of 2024. This compares to a net loss of $73.4 million, or $1.18 per share, for the comparable period of 2023.
•Cash, Cash Equivalents, and Marketable Securities: Cash, cash equivalents and marketable securities were $573.0 million as of March 31, 2024.

Conference Call Information

SpringWorks will host a conference call and webcast today, Thursday, May 2, at 8:30 a.m. ET to review its first quarter 2024 financial results and discuss recent business updates. To join the live webcast and view the corresponding slides, please click here. To access the live call by phone, please pre-register for the call by clicking here. Once registration is complete, participants will be provided with a dial-in number and conference code to access the call. A replay of the webcast will be available for a limited time following the event on the Investors and Media section of the Company’s website at View Source

On May 2, 2024 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported first quarter 2024 financial results and corporate highlights (Press release, Relay Therapeutics, MAY 2, 2024, View Source [SID1234642597]).

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"We have started 2024 with a focus on maintaining strong execution across our portfolio," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "We continue to progress a robust RLY-2608 development program and expect to share additional data in the second half of the year. In parallel, we have continued to advance our pre-clinical pipeline and look forward to disclosing at least one new program this year, which is being designed to have first-in-class potential."

Recent Corporate Highlights

RLY-2608 (ReDiscover study)

•
RLY-2608 doublet: continued to enroll patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer in two additional dose expansion cohorts of RLY-2608 in combination with fulvestrant – a second 600mg BID cohort as well as one at 400mg BID
•
RLY-2608 triplet: continued enrollment of RLY-2608 + fulvestrant + ribociclib triplet combination in patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer
Lirafugratinib (RLY-4008; ReFocus study)

•
As previously disclosed, the company will minimize resource allocation in 2024 to allow data to mature and inform future clinical development decisions
Anticipated 2024 Milestones

•
RLY-2608
o
RLY-2608 + fulvestrant data update in the second half of 2024
o
RLY-2608 + fulvestrant + ribociclib initial safety data in the second half of 2024
•
Lirafugratinib: tumor agnostic data and regulatory update in the second half of 2024
•
Pre-clinical: disclose new program(s) in 2024

First Quarter 2024 Financial Results

Cash, Cash Equivalents and Investments: As of March 31, 2024, cash, cash equivalents and investments totaled $749.6 million compared to $750.1 million as of December 31, 2023. The company expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2026.

Revenue: Revenue was $10.0 million for the first quarter of 2024, as compared to $0.2 million for the first quarter of 2023. The increase was primarily due to a payment of $10.0 million in connection with a milestone achieved under the company’s Collaboration and License Agreement with Genentech, Inc. during the first quarter of 2024.

R&D Expenses: Research and development expenses were $82.4 million for the first quarter of 2024, as compared to $82.8 million for the first quarter of 2023. The decrease was primarily due to the impact of prioritization of certain programs in our pipeline, as previously disclosed in 2023 and earlier in 2024.

G&A Expenses: General and administrative expenses were $19.8 million for the first quarter of 2024, as compared to $19.6 million for the first quarter of 2023. The increase was primarily due to additional stock compensation expense.

Net Loss: Net loss was $81.4 million for the first quarter of 2024, or a net loss per share of $0.62, as compared to a net loss of $94.2 million for the first quarter of 2023, or a net loss per share of $0.78.

On May 2, 2024 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the first quarter of 2024 and provided a business update (Press release, Regeneron, MAY 2, 2024, View Source [SID1234642596]).

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"The Regeneron team has already made substantial progress this year, delivering our approved medicines to more patients around the globe, advancing our pipeline consisting of dozens of clinical-stage programs, and relentlessly pursuing cutting-edge science," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We had a strong quarter of EYLEA HD uptake, and we are well positioned to continue our leadership in retinal diseases. Dupixent continues to grow at a remarkable pace seven years into its launch and is currently treating over 850,000 patients across a variety of diseases characterized by type 2 inflammation. Our promising oncology franchise is strengthening, driven by strong global growth in Libtayo sales and potential regulatory approvals later this year for linvoseltamab in relapsed/refractory multiple myeloma."

Financial Highlights

($ in millions, except per share data) Q1 2024 Q1 2023 % Change
Total revenues $ 3,145 $ 3,162 (1% )
Total revenues excluding Ronapreve(a)(b) $ 3,145 $ 2,940 7%
GAAP net income $ 722 $ 818 (12% )
GAAP net income per share – diluted $ 6.27 $ 7.17 (13% )
Non-GAAP net income(a) $ 1,116 $ 1,168 (4% )
Non-GAAP net income per share – diluted(a) $ 9.55 $ 10.09 (5% )

"We are off to a strong start in 2024 as reflected in our solid first quarter financial results and the progress we have made across our growing pipeline," said Christopher Fenimore, Senior Vice President, Finance and Chief Financial Officer of Regeneron. "While investing in innovation remains our top capital allocation priority, the recent authorization by Regeneron’s board of directors of a new $3.0 billion share repurchase program provides us with additional flexibility to continue returning capital to shareholders over time."

Business Highlights

Key Pipeline Progress
Regeneron has over 35 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

EYLEA HD (aflibercept) 8 mg

In January 2024, the European Commission (EC) and Japan’s Ministry of Health, Labour and Welfare (MHLW) each approved EYLEA 8 mg (known as EYLEA HD in the United States) for the treatment of patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
In January 2024, the United States Centers for Medicare & Medicaid Services (CMS) assigned a permanent and product-specific J-code (J0177) for EYLEA HD, which became effective on April 1, 2024. J-codes simplify and streamline the billing and reimbursement processes for Medicare Part B treatments, allowing for efficient claims processing.
Dupixent (dupilumab)

The U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent as an add-on maintenance treatment in adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation. A regulatory application is also under review in the European Union (EU) and Japan.
A Phase 3 study for Dupixent in asthma for children aged 2 to 5 years was initiated.
In February 2024, the MHLW in Japan approved Dupixent for the treatment of chronic spontaneous urticaria (CSU) in adults and children aged 12 years and older whose disease is not adequately controlled with existing therapy. A regulatory application has also been submitted in the EU.
Oncology Programs

The FDA accepted the BLA seeking accelerated approval for linvoseltamab, a bispecific antibody targeting BCMA and CD3, to treat adult patients with relapsed/refractory (R/R) multiple myeloma that has progressed after at least three prior therapies, and the BLA was granted priority review with a target action date of August 22, 2024. A Phase 3 confirmatory trial is currently enrolling patients. A regulatory application is also under review in the EU.
In April 2024, the Company presented positive pivotal data from the Phase 1/2 trial of linvoseltamab in patients with R/R multiple myeloma at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024. The linvoseltamab data reinforced previously shared findings and included a 71% objective response rate (ORR), with 46% of patients achieving a complete response (CR) or better.
In March 2024, the FDA issued Complete Response Letters (CRLs) for the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in R/R follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL). The only approvability issue cited in the CRLs is related to the enrollment status of the confirmatory trials. The CRLs (one for R/R FL and one for R/R DLBCL) did not identify any approvability issues with the clinical efficacy or safety, trial design, labeling, or manufacturing. A regulatory application for R/R DLBCL and R/R FL remains under review in the EU.
In 2023, the Company initiated a Phase 2/3 study of the combination of fianlimab, an antibody to LAG-3, and Libtayo (cemiplimab) in first-line metastatic melanoma. This study is enrolling faster than expected and will be conducted solely as a Phase 3 study with the final analysis to be reported during 2025.
Other Programs

The FDA has extended the approval of Praluent (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
A Phase 2 study for itepekimab, an antibody to IL-33, for non-cystic fibrosis bronchiectasis (NCFB) was initiated.
A Phase 2 study for ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP), was initiated by the Company’s collaborator Alnylam Pharmaceuticals, Inc. in patients with cerebral amyloid angiopathy (CAA).
Corporate and Business Development Updates

In April 2024, the Company acquired full development and commercialization rights to 2seventy bio, Inc.’s oncology and autoimmune preclinical and clinical stage cell therapy pipeline. Under the terms of the agreement, the Company made a $5 million up-front payment, and has assumed ongoing program, infrastructure, and personnel costs related to the product candidates acquired. In addition, the Company is obligated to pay 2seventy bio a regulatory milestone upon the first major market approval of the first approved product; and, with respect to any approved product, a low single-digit percent royalty on sales.
In April 2024, the Company and Mammoth Biosciences, Inc. entered into a collaboration agreement to research, develop, and commercialize in vivo CRISPR-based gene editing therapies for multiple tissues and cell types. Under the terms of the agreement, the Company purchased an aggregate of $95 million of Mammoth preferred stock and is obligated to make a $5 million up-front payment. The parties will jointly select and research collaboration targets, and then Regeneron will lead development and commercialization.
In April 2024, the Company’s board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of the Company’s common stock. Repurchases may be made from time to time at management’s discretion through a variety of methods. The program has no time limit and can be discontinued at any time.
First Quarter 2024 Financial Results
Revenues

($ in millions) Q1 2024 Q1 2023 % Change
Net product sales:
EYLEA HD – U.S. $ 200 $ — *

EYLEA – U.S. 1,202 1,434 (16% )
Total EYLEA HD and EYLEA – U.S. 1,402 1,434 (2% )
Libtayo – Global 264 177 49%
Praluent – U.S. 70 40 75%
Evkeeza – U.S. 24 15 60%
Inmazeb – Global 1 2 *
Total net product sales 1,761 1,668 6%

Collaboration revenue:
Sanofi 910 798 14%
Bayer 356 357 —%
Other 1 223 (100% )
Other revenue 117 116 1%
Total revenues $ 3,145 $ 3,162 (1% )

* Percentage not meaningful

Net product sales of EYLEA in the U.S. decreased in the first quarter of 2024, compared to the first quarter of 2023, primarily due to changing market dynamics, resulting in lower volumes and a lower net selling price. In addition, aggregate net product sales of EYLEA and EYLEA HD in the first quarter of 2024 were negatively impacted by approximately $40 million due to a sequential net reduction in wholesaler inventory.

Sanofi collaboration revenue increased in the first quarter of 2024, compared to the first quarter of 2023, primarily due to the Company’s share of profits from commercialization of antibodies, which were $804 million in the first quarter of 2024, compared to $637 million in the first quarter of 2023. The change in the Company’s share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales.

The decrease in other collaboration revenue in the first quarter of 2024, compared to the first quarter of 2023, was due to lower sales of Ronapreve. Under the Company’s Roche collaboration agreement, the Company records collaboration revenue in connection with payments from Roche attributable to gross profits from sales of Ronapreve; however, the Company does not expect any additional Roche collaboration revenue from Ronapreve in future periods.

Refer to Table 4 for a summary of collaboration revenue.

Operating Expenses

GAAP %
Change
Non-GAAP(a) %
Change
($ in millions) Q1 2024 Q1 2023 Q1 2024 Q1 2023
Research and development (R&D) $ 1,248 $ 1,101 13% $ 1,122 $ 960 17%
Acquired in-process research and development (IPR&D) $ 7 $ 56 (88% ) * * n/a
Selling, general, and administrative (SG&A) $ 689 $ 601 15% $ 584 $ 515 13%
Cost of goods sold (COGS) $ 240 $ 208 15% $ 196 $ 168 17%
Cost of collaboration and contract manufacturing (COCM) $ 193 $ 249 (22% ) * * n/a
Other operating expense (income), net $ 15 $ (1 ) ** $ — * **

* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded.
** Percentage not meaningful
GAAP and non-GAAP R&D expenses increased in the first quarter of 2024, compared to the first quarter of 2023, driven by the advancement of the Company’s late-stage oncology programs, and higher headcount and headcount-related costs.
Acquired IPR&D for first quarter of 2023 included a $45 million up-front payment in connection with the Company’s collaboration agreement with Sonoma Biotherapeutics, Inc.
GAAP and non-GAAP SG&A expenses increased in the first quarter of 2024, compared to the first quarter of 2023, due to higher commercialization-related expenses to support the Company’s launch of EYLEA HD and higher headcount and headcount-related costs primarily related to the international expansion in support of Libtayo and hematology product launch preparations.
GAAP and non-GAAP COGS increased in the first quarter of 2024, compared to the first quarter of 2023, primarily due to higher start-up costs for the Company’s Rensselaer, New York fill/finish facility.
COCM decreased in the first quarter of 2024, compared to the first quarter of 2023, primarily due to lower Dupixent manufacturing costs as a result of the transition to a higher-yielding manufacturing process.
GAAP other operating expense (income), net, for the first quarter of 2024 reflects a charge related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with the Company’s 2023 acquisition of Decibel Therapeutics, Inc.

On May 2, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2024 (Press release, Puma Biotechnology, MAY 2, 2024, View Source [SID1234642595]). Unless otherwise stated, all comparisons are for the first quarter 2024 compared to the first quarter 2023.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the first quarter of 2024 was $40.3 million, compared to product revenue, net of $46.8 million in the first quarter of 2023.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $4.8 million, or $0.10 per basic and diluted share, for the first quarter of 2024, compared to net income of $1.4 million, or $0.03 per basic and diluted share, for the first quarter of 2023.

Non-GAAP adjusted net loss was $2.4 million, or $0.05 per basic and diluted share, for the first quarter of 2024, compared to non-GAAP adjusted net income of $4.2 million, or $0.09 per basic and diluted share, for the first quarter of 2023. Non-GAAP adjusted net (loss) income excludes stock-based compensation expense. For a reconciliation of GAAP net (loss) income to non-GAAP adjusted net (loss) income and GAAP net (loss) income per share to non-GAAP adjusted net (loss) income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the first quarter of 2024 was $11.3 million, compared to $2.6 million in the first quarter of 2023. At March 31, 2024, Puma had cash, cash equivalents and marketable securities of $107.2 million, compared to cash, cash equivalents and marketable securities of $96.0 million at December 31, 2023.

"In February, we were pleased to initiate ALISertib in CAncer (ALISCA-Lung1), a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We also look forward to presenting updated data from the clinical trial of alisertib in combination with osimertinib in patients with metastatic EGFR-mutant non-small cell lung cancer who have developed osimertinib resistance, as well as results from the biomarker studies of the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor-positive, HER2-negative breast cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. We remain committed to our goal to clinically develop alisertib, while carefully managing our resources to achieve positive net income for this year."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of biomarker studies from the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor-positive, HER2-negative breast cancer (Q2 2024); (ii) updated data from the clinical trial of alisertib in combination with osimertinib in patients with metastatic EGFR-mutant non-small cell lung cancer who have developed osimertinib resistance (Q2 2024); (iii) initiation of ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2024); and (iv) interim data from ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q4 2024)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the first quarter ended March 31, 2024, total revenue was $43.8 million, of which $40.3 million was net product revenue and $3.5 million was royalty revenue. This compares to total revenue of $52.8 million in the first quarter of 2023, of which $46.8 million was net product revenue and $6.0 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $46.1 million for the first quarter of 2024, compared to $48.4 million for the first quarter of 2023.

Cost of Sales

Cost of sales was $10.7 million for the first quarter of 2024, compared to $13.2 million for the first quarter of 2023. The $2.5 million decrease resulted primarily from lower royalty expense reflecting decreased worldwide net sales.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $21.8 million for the first quarter of 2024, compared to $22.5 million for the first quarter of 2023. The $0.7 million decrease resulted primarily from payroll-related expenses and stock-based compensation, partially offset by an increase in professional fees and expenses.

Research and Development Expenses

Research and development expenses were $13.6 million for the first quarter of 2024, compared to $12.7 million for the first quarter of 2023. The $0.9 million increase resulted primarily from an increase in clinical trial expense of approximately $1.0 million, due to a milestone payment associated with a neratinib clinical trial, partially offset by a decrease in neratinib-related consultant and contractors expense.

Total Other Income (Expenses)

Total other expenses were $2.3 million for the first quarter of 2024, compared to total other expenses of $2.8 million for the first quarter of 2023. The $0.5 million decrease resulted primarily from an increase in interest income, which resulted from higher interest rates and increased cash investments.

Second Quarter and Full Year 2024 Financial Outlook

Second Quarter 2024

Full Year 2024

Net Product Revenue

$43 -45 million

$183 – $190 million

Royalty Revenue

$2.5 – $3 million

$30 – $33 million

License Revenue

$0 million

$1 – $2 million

Net Income/(Loss)

$(6) – $(9) million

$12 – $15 million

Gross to Net Adjustment

22% – 23%

21.5% – 22.5%

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2024 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 2, 2024. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

On May 2, 2024 Pulse Biosciences, Inc. (Nasdaq: PLSE) ("Pulse" or the "Company"), a company leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology, reported that the Company’s Board of Directors has set the record date for the Company’s previously announced rights offering (the "Rights Offering"), which will be available to all holders of record of the Company’s common stock, par value $0.001 per share (the "Common Stock"), as of the close of the market on Thursday, May 16, 2024 (the "Record Date") (Press release, Pulse Biosciences, MAY 2, 2024, View Source [SID1234642594]).

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The Company intends to distribute to all holders of Common Stock as of the Record Date non-transferable subscription rights to purchase up to an aggregate of 6,000,000 units ("Units") at a price per Unit equal to the lesser of: (i) $10 (the "Initial Price") and (ii) the volume weighted average price of the Common Stock for the ten trading day period through and including the expiration date of the Rights Offering, currently contemplated to be Thursday, June 13, 2024 (the "Alternate Price"). Only persons who own Company stock on the May 16, 2024 Record Date will be able to participate in the Rights Offering. Assuming that the Rights Offering is fully subscribed, the Company will receive gross proceeds of $60,000,000, less expenses related to the Rights Offering. As indicated below, please refer to the Registration Statement on Form S-3, as amended, for more complete information regarding the planned Rights Offering.

Each stockholder will receive one subscription right entitling the holder to purchase a fraction of a Unit for each share of Common Stock owned at 5:00 p.m., Eastern Time, on the Record Date. Each Unit shall consist of one share of Common Stock and two warrants, each being a warrant to purchase one-half of one share of Common Stock at an exercise price per whole share that shall be equal to 110% of the per-Unit subscription price (provided, that, the aggregate number of shares of Common Stock that shall be issuable upon the exercise of each set of warrants included in a given subscription for Units shall be rounded up to the nearest whole share). Each warrant will be exercisable immediately upon completion of the Rights Offering and will expire on the fifth anniversary of the completion of the Rights Offering. The respective warrants will be subject to redemption by the Company for $0.01 per underlying share of Common Stock, on not less than thirty (30) days’ written notice, if the volume weighted average price of our Common Stock equals or exceeds: (i) in respect of one such warrant, 150% of the exercise price for the warrants, subject to adjustment, per whole share, for twenty (20) consecutive trading days, and (ii) in respect of the other such warrant, 200% of the exercise price for the warrants, subject to adjustment, per whole share, for twenty (20) consecutive trading days, provided that, in each case, the Company may not redeem the warrants prior to the date that is three months after the issuance date. To the extent that the Alternate Price is lower than the Initial Price, the Company will sell additional Units, but will not sell fractional Units.

The Rights Offering will include an over-subscription right to permit each rights holder that exercises its basic subscription rights in full to purchase additional Units that remain unsubscribed at the expiration of the offering, but the Company will not sell fractional Units. The availability of this over-subscription right will be subject to certain terms and conditions to be set forth in the offering documents.

Pulse has filed a registration statement (including a prospectus) on Form S-3 with the U.S. Securities and Exchange Commission (the "SEC") on April 3, 2024, as amended on each of April 15, 2024, April 23, 2024, April 25, 2024, and April 30, 2024 (the "Registration Statement"), which has not yet become effective. The Registration Statement covers, among other things, the Rights Offering to which this communication relates. The Units, and the securities comprising such Units, may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective. Before you invest, you should read the final prospectus in the Registration Statement, together with any prospectus supplement, that we will file prior to commencing any Rights Offering, and the documents incorporated by reference in the prospectus (or any prospectus supplement), as well as the other documents Pulse has filed with the SEC for more complete information about Pulse and the Rights Offering. You may get these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov.

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