On May 9, 2023 Verrica Pharmaceuticals Inc. ("Verrica" or "the Company") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the first quarter ended March 31, 2023 (Press release, Verrica Pharmaceuticals, MAY 9, 2023, View Source [SID1234631301]).

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"The first quarter of 2023 saw continued execution across our pipeline and strengthening of our financial position," said Ted White, Verrica’s President and Chief Executive Officer. "With the upcoming PDUFA goal date of July 23, we may be poised to reach a major inflection point with the potential approval of YCANTH for the treatment of molluscum contagiosum. Molluscum is a dermatological condition that afflicts millions of children each year in the U.S., and with no FDA approved therapies, we believe YCANTH has the potential to address this significant unmet medical need. We also made progress with our novel oncolytic peptide, VP-315, which advanced into the second part of our ongoing Phase 2 study in basal cell carcinoma in April 2023 following a positive safety assessment and promising signs of activity from Part 1 of the study.

"We also had the opportunity to strengthen our balance sheet during the quarter, raising an additional $32.5 million in gross proceeds in an underwritten offering to further extend our cash runway. This additional capital will help support our pre-commercial activities for YCANTH and fund our ongoing VP-315 Phase 2 study. Looking ahead, we are excited about the progress we expect to make throughout the remainder of the year."

Business Highlights and Recent Developments

VP-102

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On February 27, 2023, the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) of July 23, 2023, for Verrica’s New Drug Application (NDA) for YCANTH (VP-102), which is being developed for the treatment of molluscum contagiosum (molluscum).

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On January 4, 2023, Verrica announced the successful completion of the technology transfer of bulk solution manufacturing of YCANTH to Piramal Pharma Solutions. The technology transfer includes the completion of the registration batch material, which has been placed on stability, and the manufacture of three process validation batches of bulk solution.

VP-315

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On April 12, 2023, Verrica announced that the first patient has been dosed in Part 2 of a Phase 2 study evaluating the Company’s potentially first-in-class oncolytic peptide, VP-315, for the treatment of basal cell carcinoma. Part 2 of the Phase 2 trial is designed to further explore dosing regimens to identify the recommended dose for Part 3 of the study, which is expected to start in the first half of 2024.

Underwritten Offering

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On February 21, 2023, the Company announced the pricing of a $32.5 million underwritten offering of common stock and pre-funded warrants.

Financial Results

First Quarter 2023 Financial Results

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Verrica recognized collaboration revenues of $37,000 in the first quarter of 2023 compared to $0.4 million for the same period in 2022 related to the Collaboration and License Agreement with Torii Pharmaceutical Col, Ltd ("Torii"). The collaboration revenue consists of supplies and development activity with Torii.

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Research and development expenses were $2.7 million in the first quarter of 2023, compared to $2.4 million for the same period in 2022. The increase was primarily attributable to additional CMC costs related to our development of VP-102 for molluscum.

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General and administrative expenses were $4.3 million in the first quarter of 2023, compared to $5.1 million for the same period in 2022. The decrease was primarily related to lower compensation costs due to a reduction in headcount.

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Costs of collaboration revenue were $68,000 for the first quarter of 2023, compared to $0.3 million for the same period in 2022. The decrease of $0.2 million was primarily due to less manufacturing supply required to support development and testing services pursuant to the Torii Clinical Supply Agreement.

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For the first quarter of 2023, net loss on a GAAP basis was $6.6 million, or $0.15 per share, compared to a net loss of $8.5 million, or $0.31 per share, for the same period in 2022.

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For the first quarter of 2023, non-GAAP net loss was $5.5 million, or $0.13 per share, compared to a non-GAAP net loss of $6.8 million, or $0.25 per share, for the same period in 2022.

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As of March 31, 2023, Verrica had aggregate cash and cash equivalents of $60.0 million. The Company believes that its existing cash and cash equivalents as of March 31, 2023, will be sufficient to support planned operations into the first quarter of 2024.

Non-GAAP Financial Measures

In evaluating the operating performance of its business, Verrica’s management considers non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.

About YCANTH (VP-102)

YCANTH (VP-102) is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. If approved, YCANTH would be the only product approved by the FDA to treat molluscum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

About VP-315

VP-315 is a potentially first-in-class oncolytic peptide immunotherapy in development as a non-surgical treatment option for non-melanoma skin cancers. The Phase 2 trial is a three-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. The study is expected to enroll approximately 66 adult subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include expectations regarding the

approval of VP-102 for the treatment of molluscum, the timing of clinical trial completion for VP-315 and Verrica’s cash and cash equivalents being sufficient to support planned operations into the first quarter of 2024. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2022 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

On May 9, 2023 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported that its Chief Executive Officer, Nancy Simonian, M.D., will participate in a fireside chat at the JMP Securities 2023 Life Sciences Conference (Press release, Syros Pharmaceuticals, MAY 9, 2023, View Source [SID1234631300]). Management will also be available for one-on-one meetings. Details are as follows:

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JMP Securities 2023 Life Sciences Conference

Date: Tuesday, May 16
Time: 10:00 a.m. ET
Location: The New York Hilton Midtown, 1335 Avenue of the Americas, New York, NY

A live webcast of the fireside chat will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On May 9, 2023, Madrigal Pharmaceuticals, Inc. (the "Company") reported to have entered into Amendment No. 1 (the "Amendment") to the Sales Agreement dated June 1, 2021 (as amended, the "Sales Agreement") with Cowen and Company, LLC ("Cowen"), which Amendment increases by up to an additional $200,000,000 the amount of the Company’s common stock, par value $0.0001 per share (the "Common Stock") that can be issued and sold by the Company from time to time through or to Cowen, acting as agent or principal (the "ATM Offering") (Filing, 8-K, Madrigal Pharmaceuticals, MAY 9, 2023, View Source [SID1234631299]).

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Sales of the Common Stock, if any, under the Sales Agreement will be made by any method that is deemed to be an "at the market" offering as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. The Company has no obligation to sell any of the Common Stock and may at any time suspend offers under the Sales Agreement or terminate the Sales Agreement pursuant to its terms.

Subject to the terms and conditions of the Sales Agreement, Cowen will use its commercially reasonable efforts to sell the shares of Common Stock from time to time, as the sales agent, based upon the Company’s instructions. The offering of shares of Common Stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Common Stock subject to the Sales Agreement or (ii) the termination of the Sales Agreement in accordance with its terms.

The foregoing description of Amendment to the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Amendment, a copy of which is incorporated herein by reference as Exhibit 1.1.

The Common Stock to be sold under the Sales Agreement, if any, will be issued and sold pursuant to the Company’s automatic shelf registration statement on Form S-3 (File No. 333-256666), filed with the Securities and Exchange Commission ("SEC") on June 1, 2021. On May 9, 2023, the Company filed a prospectus supplement with the SEC in connection with the offer and sale of the additional $200,000,000 of Common Stock pursuant to the Amendment to the Sales Agreement. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock nor shall there be any sale of the Common Stock in any state or 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 other jurisdiction. The legal opinion of Hogan Lovells US LLP relating to the legality of the issuance and sale of the Common Stock pursuant to the ATM Offering is attached as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated by reference herein.

On May 9, 2023 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the first quarter of 2023, and associated Company developments (Press release, Supernus, MAY 9, 2023, View Source [SID1234631298]).

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"We are pleased with the strong revenue and earnings performance despite the entry of generic Trokendi XR in the first quarter of 2023," said Jack Khattar, President and CEO of Supernus. "Excluding Trokendi XR, first quarter 2023 net product sales increased 25%, driven by the continued adoption of Qelbree across both pediatric and adult patients and growing demand for GOCOVRI. We remain well-positioned to drive strong revenue and operating earnings growth in 2024 and beyond."

Qelbree Launch Update

Total IQVIA prescriptions were 134,530 in the first quarter of 2023, an increase of 14% compared to total prescriptions of 117,635 in the fourth quarter of 2022. In March 2023, the most recent month available, total prescriptions reached 49,789.
Qelbree continues to expand its base of prescribers, with approximately 19,197 prescribers in the first quarter of 2023, up from 16,822 prescribers from the fourth quarter of 2022.
As previously disclosed, the Company executed a second significant pharmacy benefit manager contract, effective January 2023. We continue making progress in securing and improving managed care coverage.
Product Pipeline Update

SPN-830 (apomorphine infusion device) – Continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease (PD)

In April 2023, the Company had a constructive meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter received in October 2022. Based on this meeting, the Company expects to resubmit the New Drug Application for SPN-830 in the fourth quarter of 2023.
SPN-820 – Novel first-in-class activator of mTORC1 for the treatment of treatment-resistant depression

The Phase II multi-center randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression is ongoing. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 270 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, a standard depression rating scale.
SPN-817 – A novel product candidate for the treatment of epilepsy

The open-label Phase II clinical study of SPN-817 in patients with treatment-resistant seizures is ongoing. Depending on the rate of enrollment, the Company expects to have data in the first half of 2024.
R&D Day

Supernus will host an R&D Day in New York City in the Fall of 2023. The management team plans to provide an overview of the Company’s pipeline, including SPN-830, SPN-820, SPN-817 and new clinical candidates from the Company’s discovery program. Further details are forthcoming.
Financial Highlights

Total revenues

For the three months ended March 31, 2023, total revenues were $153.8 million, compared to total revenues of $152.5 million for the same period in 2022. Net product sales were $140.6 million, compared to net product sales of $147.5 million for the same period in 2022. The decrease in net product sales was primarily due to a decrease in net product sales of Trokendi XR, partially offset by an increase in net product sales of both Qelbree and GOCOVRI. Excluding net product sales of Trokendi XR, first quarter 2023 total net product sales increased 25% compared to the same quarter last year.

The following table provides information regarding total revenues during the three months ended March 31, 2023 and 2022 (dollars in millions):

Three Months Ended March 31,
2023 2022 Change %
Net product sales
Trokendi XR $ 34.8 $ 62.8 (45)%
Oxtellar XR 28.9 27.5 5%
GOCOVRI 26.0 22.6 15%
Qelbree 25.8 8.3 **
APOKYN 17.2 18.5 (7)%
Other(1) 7.9 7.8 1%
Total net product sales $ 140.6 $ 147.5 (5)%
Royalty revenues 13.2 5.0 **
Total revenues $ 153.8 $ 152.5 1%
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(1) Includes net product sales of MYOBLOC, XADAGO and Osmolex ER.
** Indicates calculation result is greater than 100%.

Operating earnings (GAAP and non-GAAP)

First quarter 2023 operating earnings (GAAP) was $5.2 million, as compared to operating earnings (GAAP) of $2.0 million for the same period in 2022. The increase was primarily due to growth in net product sales of Qelbree and GOCOVRI and an increase in royalty revenues, partially offset by a decrease in net product sales of Trokendi XR, as well as a decrease in operating expenses.

First quarter 2023 adjusted operating earnings (non-GAAP) were $30.5 million, as compared to $28.0 million for the first quarter of 2022.

Reconciliation of GAAP to Non-GAAP Adjustments

An itemized reconciliation between operating earnings on a GAAP basis and operating earnings on a non-GAAP basis is as follows (dollars in millions):

Three Months Ended
March 31, 2023 Three Months Ended
March 31, 2022
Operating earnings – As Reported (GAAP) $ 5.2 $ 2.0
Adjustments:
Amortization of intangible assets 20.0 20.6
Share-based compensation 6.3 4.0
Contingent consideration expense (gain) (1.6 ) 0.7
Depreciation 0.6 0.7
Operating earnings – As Adjusted (non-GAAP) $ 30.5 $ 28.0
Non-GAAP operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation.

Net earnings (GAAP)

First quarter 2023 net earnings (GAAP) and diluted earnings per share (GAAP) were $16.9 million and $0.29, respectively, as compared to $25.6 million, or $0.43, in the same period in 2022.

Balance sheet

At March 31, 2023, the Company’s cash, cash equivalents, restricted cash, current and long-term marketable securities were approximately $686.5 million, compared to $555.2 million as of December 31, 2022. This increase was primarily due to cash generated from operations and the net amount drawn from the line of credit.

On April 1, 2023, the Company paid the total principal amount of $402.5 million due under its 0.625% Convertible Senior Notes due 2023 (2023 Notes), in addition to payment of the remaining outstanding interest due of $1.3 million. Following the repayment, the 2023 Notes are no longer outstanding. The repayment of the 2023 Notes at maturity was financed primarily with available cash on hand and, to a lesser extent, through borrowing under the Company’s existing credit line agreement. The outstanding balance under the credit line as of March 31, 2023 of $78.4 million is expected to be fully repaid by the end of the second quarter 2023.

Full Year 2023 Financial Guidance (GAAP)

For the full year 2023, the Company is increasing prior financial guidance for GAAP operating loss and non-GAAP operating earnings, lowering financial guidance for combined R&D and SG&A expenses, and maintaining its financial guidance for total revenues as set forth below (dollars in millions).

Amount
Total revenues (1) (Includes $60 million to $80 million of Trokendi XR(2)) $580 – $620
Combined R&D and SG&A expenses $450 – $480
Operating loss (3) $(30) – $(10)
___________________________________________
(1) Includes net product sales and royalty revenue.
(2) Reflects generic entry on Trokendi XR in 2023.
(3) Includes amortization of intangible assets and contingent consideration expense (gain).

Full Year 2023 Financial Guidance – GAAP to Non-GAAP Adjustments

An itemized reconciliation between projected operating loss on a GAAP basis and projected operating earnings on a non-GAAP basis is as follows (dollars in millions):

Amount
Operating loss – GAAP $(30) – $(10)
Adjustments:
Amortization of intangible assets $80
Share-based compensation $20 – $24
Contingent consideration $0 – $1
Depreciation $5
Operating earnings – non-GAAP $75 – $100
Non-GAAP Financial Information

This press release contains a financial measure, non-GAAP operating earnings, which does not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP operating earnings adjusts for non-cash share-based compensation expense, depreciation and amortization, and accretion of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. We believe the use of non-GAAP operating earnings is useful supplemental information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. There are limitations associated with the use of non-GAAP financial measures. Including such measures may not be entirely comparable to similarly titled measures used by other companies, may not reflect all items of income and expense, as applicable, that affect our operations, potential differences among calculation methodologies, may differ from the non-GAAP information used by other companies, including peer companies, and therefore comparability may be limited. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2023 financial guidance is also being provided on both a reported and a non-GAAP basis.

Conference Call Details

Supernus will host a conference call and webcast today, May 9, 2023, at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.

On May 9, 2023 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a commercial stage biopharmaceutical company focused on novel and targeted oncology therapies, reported its financial results for the three-month period ended March 31, 2023, and provided a corporate update (Press release, Spectrum Pharmaceuticals, MAY 9, 2023, View Source [SID1234631297]).

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First Quarter 2023 and Recent Business Update

Net sales for Q1 2023 totaled $15.6 million, an increase of 54% compared to Q4 2022.
172 targeted accounts purchased ROLVEDON (eflapegrastim-xnst) Injection during the quarter compared to 70 in Q4 2022, an increase of 145%.
Permanent J-Code for ROLVEDON went into effect on April 1, facilitating more efficient and predictable reimbursement in the outpatient setting.
On April 25, announced acquisition by Assertio Holdings, Inc. (Nasdaq: ASRT) ("Assertio"), a specialty pharmaceutical company offering differentiated products to patients, in an all-stock and CVR transaction which is expected to deliver immediate value to stockholders while providing the opportunity to share in future upside of ROLVEDON.
Upfront consideration represents a premium of 65%, and the total potential consideration a premium of 94% to Spectrum’s closing price of $0.69 on April 24, 2023.
Following an anticipated Q3 2023 closing, Assertio stockholders will own approximately 65% of the combined company, and Spectrum stockholders will own approximately 35% of the combined company, on a fully diluted basis.
"Spectrum delivered a strong start to 2023 with outstanding execution in the launch of ROLVEDON. This success is demonstrated through significant quarter-over-quarter sales growth, account expansion, and continued customer receptivity to ROLVEDON’s value proposition," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "Following the acquisition, we believe the combination of Spectrum’s commercial infrastructure and Assertio’s digital non-personnel resources will set the brand up for long-term success and accelerate the profitability of the combined company."

Financial Results for the Quarter Ended March 31, 2023 (All numbers are from Continuing Operations)

Net sales for the first quarter of 2023 were $15.6 million. During the fourth quarter of 2022 we began to sell our sole commercial product, ROLVEDON, which was approved by the FDA on September 9, 2022. We had no sales during the first quarter of 2022.

Total cost of sales was $1.1 million for the quarter ended March 31, 2023, and consisted primarily of royalties associated with net sales of ROLVEDON, stability testing and packaging costs. This figure did not include any direct costs associated with the manufacture of ROLVEDON, which were previously expensed as research and development expense. As we sell through certain inventory that was expensed prior to FDA approval of ROLVEDON, we expect the cost of sales to remain low through the first nine months of 2023 and to increase thereafter.

Selling, general and administrative expenses for the first quarter of 2023 increased by $4.1 million to $14.0 million as compared to the corresponding prior year period. The increase was due primarily to increased sales and marketing expenses to support the launch of ROLVEDON and an increase in legal and other fees incurred in connection with the pending acquisition by Assertio.

Research and development expenses increased for the three months ended March 31, 2023 by $1.2 million to $5.4 million as compared to the comparable period ended March 31, 2022. The current period had decreased personnel expenses of $5.7 million related to the reduction in workforce during the strategic restructuring that began in January 2022 and decreased program activities of $5.0 million for poziotinib. These period over period decreases were offset by the reversal of an $11.2 million ROLVEDON drug substance accrual during the quarter ended March 31, 2022, which was a concession provided by Hanmi for drug substance which had been accrued during 2021 and is no longer payable.

Net loss from continuing operations was $5.0 million, or $0.02 per basic and diluted share, for the quarter ended March 31, 2023, compared to a net loss of $15.4 million, or $0.09 per basic and diluted share, for the comparable period in 2022.

The Company had a total cash, cash equivalents, and marketable securities balance of approximately $56.1 million as of March 31, 2023.

About ROLVEDON

ROLVEDON (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. The BLA for ROLVEDON was supported by data from two similarly designed Phase 3, randomized, open-label, noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLVEDON in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLVEDON demonstrated the pre-specified hypothesis of non-inferiority (NI) in mean duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLVEDON also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles (all NI p<0.0001) in both trials.

Please see the Important Safety Information below and the full prescribing information for ROLVEDON at www.rolvedon.com.

Indications and Usage

ROLVEDON is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

Limitations of Use

ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information

Contraindications

ROLVEDON is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim or filgrastim products. Reactions may include anaphylaxis.
Warnings and Precautions

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute Respiratory Distress Syndrome (ARDS)

ARDS can occur in patients receiving rhG-CSF products. Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue ROLVEDON in patients with ARDS.
Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products. Permanently discontinue ROLVEDON in patients who experience serious allergic reactions.
Sickle Cell Crisis in Patients with Sickle Cell Disorders

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products. Discontinue ROLVEDON if sickle cell crisis occurs.
Glomerulonephritis

Glomerulonephritis has occurred in patients receiving rhG-CSF products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation. Evaluate and consider dose reduction or interruption of ROLVEDON if causality is likely.
Leukocytosis

White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving rhG-CSF products. Monitor complete blood count (CBC) during ROLVEDON therapy. Discontinue ROLVEDON treatment if WBC count of 100 x 109/L or greater occurs.
Thrombocytopenia

Thrombocytopenia has been reported in patients receiving rhG-CSF products. Monitor platelet counts.
Capillary Leak Syndrome

Capillary leak syndrome has been reported after administration of rhG-CSF products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency and severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The granulocyte colony-stimulating factor (G-CSF) receptor through which ROLVEDON acts has been found on tumor cell lines. The possibility that ROLVEDON acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which ROLVEDON is not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer

MDS and AML have been associated with the use of rhG-CSF products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
Aortitis

Aortitis has been reported in patients receiving rhG-CSF products. It may occur as early as the first week after start of therapy. Consider aortitis in patients who develop generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) without known etiology. Discontinue ROLVEDON if aortitis is suspected.
Nuclear Imaging

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.
Adverse Reactions

The most common adverse reactions (≥20%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.
Permanent discontinuation due to an adverse reaction occurred in 4% of patients who received ROLVEDON. The adverse reaction requiring permanent discontinuation in 3 patients who received ROLVEDON was rash.
To report SUSPECTED ADVERSE REACTIONS, contact Spectrum Pharmaceuticals, Inc. at 1-888-713-0688 or FDA at 1800FDA1088 or www.fda.gov/medwatch