Spectrum Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update
Spectrum Pharmaceuticals, Inc. (SPPI) reported a net loss of $29 million for Q2 2022, reducing from a loss of $49.9 million in Q2 2021. Research and development expenses decreased to $16 million from $29.1 million, while selling, general and administrative expenses fell to $9.4 million from $15 million. The company has a cash reserve of approximately $68 million, ensuring a runway into 2023. The FDA is reviewing the Biologics License Application for eflapegrastim with a decision expected by September 9, 2022, and the New Drug Application for poziotinib is also in review with an ODAC meeting set for September 22, 2022.
- Net loss decreased from $49.9 million in Q2 2021 to $29 million in Q2 2022.
- Research and development expenses reduced significantly from $29.1 million to $16 million.
- Cash position of approximately $68 million provides a runway into 2023.
- None.
Eflapegrastim BLA under FDA review; PDUFA date
FDA completes re-inspection of drug substance manufacturing facility for eflapegrastim
Poziotinib NDA under FDA review with ODAC meeting on
Management to host webcast and conference call today at
“The completion of the FDA re-inspection of the drug substance facility for eflapegrastim is a critical step in the regulatory review process. With this hurdle behind us, we have turned our focus to our potential approval and commercialization,” said
Pipeline Updates
Eflapegrastim, a novel long-acting G-CSF
-
The Biologics License Application (BLA) for eflapegrastim is under active review at the
U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date ofSeptember 9, 2022 . The pre-approval inspection of the drug substance manufacturing facility has been completed by the FDA. The company anticipates an FDA decision by the PDUFA date and is actively preparing for the potential commercial launch.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon 20 mutations
-
The New Drug Application (NDA) for poziotinib is under active review at the FDA with Fast Track designation and a PDUFA date of
November 24, 2022 . The NDA is based on the positive results of Cohort 2 from the ZENITH20 clinical trial in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. There is currently no FDA approved therapy for patients with NSCLC harboring HER2 exon 20 insertion mutations. -
An abstract showing a high level of activity for poziotinib in patients with a G778_P780dup mutation, the second most prevalent mutation in HER2 exon 20 NSCLC, has been accepted for presentation at ESMO 2022 being held
September 9-13 inParis . The data comes from Cohorts 2 and 4 of the ZENITH20 clinical trial. - A study for poziotinib is in progress to confirm the clinical benefit seen in Cohort 2, as required for an accelerated approval. The trial, Study SPI-POZ-301 (PINNACLE), is designed to enroll 268 patients with previously treated NSCLC harboring HER2 exon 20 mutations. Patients are being randomized 2-to-1 into one of two treatment arms using 8mg of poziotinib orally administered BID (twice daily) versus 75mg/m2 of docetaxel administered intravenously every three weeks. The primary endpoint is progression free survival.
-
The FDA’s
Oncologic Drugs Advisory Committee (ODAC) is scheduled to review poziotinib for the treatment of patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations. The poziotinib ODAC review is scheduled forSeptember 22, 2022 at9 a.m. ET . ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes non-binding recommendations to the FDA. The final decision regarding the approval of the product is made solely by the FDA. -
The company presented data on the predictive ability of circulating tumor DNA (ctDNA) in poziotinib treated patients with NSCLC harboring HER2 exon 20 insertion mutations at the 2022
American Society of Clinical Oncology (ASCO) Annual Meeting in June. Preliminary results suggest that decreases in plasma ctDNA during poziotinib therapy correlate with clinical response in patients with advanced NSCLC with HER2 exon 20 insertion mutations.
Three-Month Period Ended
Spectrum recorded a net loss of
Cash Position and Guidance
The company’s cash, cash equivalents and marketable securities balance was approximately
Conference Call
To access the live call by phone, please go to this link (registration link), and you will be provided with dial in details. To avoid delays, participants are encouraged to dial into the conference call fifteen minutes ahead of the scheduled start time.
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of
About
Notice Regarding Forward-looking statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These forward-looking statements relate to a variety of matters, including, without limitation, statements that relate to Spectrum’s business and its future, including the likelihood and timing of the FDA approval of poziotinib and eflapegrastim, if FDA approval is received, the success and timing of the company’s commercialization efforts, the results of the confirmatory study for poziotinib, the results of the ODAC’s review of poziotinib and related recommendation to the FDA, the speed of enrollment in the company’s remaining ZENITH20 Cohorts, whether additional data for poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations will continue to demonstrate similar results to the preliminary data suggesting the predictive ability of circulating tumor DNA (ctDNA), the future potential of Spectrum’s existing drug pipeline, the results of the company’s strategic restructuring, the length of the company’s cash runway and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Spectrum and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. Risks that could cause actual results to differ include, but are not limited to, the uncertainties inherent in new product development, including clinical trial results and additional analysis of existing preclinical and clinical data, the possibility that Spectrum's new and existing drug candidates, including poziotinib, may not ultimately prove to be safe or effective, the possibility that Spectrum's new and existing drug candidates, if approved, may not be more effective, safer, or more cost-efficient than competing drugs and other risks that are described in further detail in the company's reports filed with the
© 2022
Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (Unaudited) |
||||||||||||||||
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|||||||||||||
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|||||||||
Operating costs and expenses: |
|
|
|
|
|
|
|
|||||||||
Selling, general and administrative |
$ |
9,385 |
|
|
$ |
14,957 |
|
|
$ |
19,255 |
|
|
$ |
29,272 |
|
|
Research and development |
|
16,007 |
|
|
|
29,114 |
|
|
|
20,200 |
|
|
|
48,485 |
|
|
Total operating costs and expenses |
|
25,392 |
|
|
|
44,071 |
|
|
|
39,455 |
|
|
|
77,757 |
|
|
Loss from continuing operations before other income (expense) and income taxes |
|
(25,392 |
) |
|
|
(44,071 |
) |
|
|
(39,455 |
) |
|
|
(77,757 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|||||||||
Interest income, net |
|
117 |
|
|
|
26 |
|
|
|
128 |
|
|
|
110 |
|
|
Other expense, net |
|
(3,757 |
) |
|
|
(5,876 |
) |
|
|
(5,091 |
) |
|
|
(7,957 |
) |
|
Total other expense |
|
(3,640 |
) |
|
|
(5,850 |
) |
|
|
(4,963 |
) |
|
|
(7,847 |
) |
|
Loss from continuing operations before income taxes |
|
(29,032 |
) |
|
|
(49,921 |
) |
|
|
(44,418 |
) |
|
|
(85,604 |
) |
|
Provision for income taxes from continuing operations |
|
(13 |
) |
|
|
(16 |
) |
|
|
(29 |
) |
|
|
(9 |
) |
|
Loss from continuing operations |
|
(29,045 |
) |
|
|
(49,937 |
) |
|
|
(44,447 |
) |
|
|
(85,613 |
) |
|
Loss from discontinued operations, net of income taxes |
|
(3 |
) |
|
|
(195 |
) |
|
|
(43 |
) |
|
|
(216 |
) |
|
Net loss |
$ |
(29,048 |
) |
|
$ |
(50,132 |
) |
|
$ |
(44,490 |
) |
|
$ |
(85,829 |
) |
|
|
|
|
|
|
|
|
|
|||||||||
Basic and diluted loss per share: |
|
|
|
|
|
|
|
|||||||||
Loss from continuing operations |
$ |
(0.17 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.57 |
) |
|
Loss from discontinued operations |
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
Net loss per share, basic and diluted |
$ |
(0.17 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.57 |
) |
|
Weighted average shares outstanding, basic and diluted |
|
175,566,757 |
|
|
|
155,243,402 |
|
|
|
172,558,831 |
|
|
|
150,334,548 |
|
|
Condensed Consolidated Balance Sheets (In thousands, except share and par value amounts) (Unaudited) |
||||||||
|
2022 |
|
2021 |
|||||
ASSETS |
|
|
|
|||||
Current assets: |
|
|
|
|||||
Cash and cash equivalents |
$ |
25,512 |
|
|
$ |
88,539 |
|
|
Marketable securities |
|
42,447 |
|
|
|
12,108 |
|
|
Other receivables |
|
608 |
|
|
|
1,028 |
|
|
Prepaid expenses and other current assets |
|
5,012 |
|
|
|
2,277 |
|
|
Total current assets |
|
73,579 |
|
|
|
103,952 |
|
|
Property and equipment, net |
|
347 |
|
|
|
455 |
|
|
Facility and equipment under lease |
|
1,703 |
|
|
|
2,505 |
|
|
Other assets |
|
3,800 |
|
|
|
4,636 |
|
|
Total assets |
$ |
79,429 |
|
|
$ |
111,548 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|||||
Current liabilities: |
|
|
|
|||||
Accounts payable and other accrued liabilities |
$ |
33,123 |
|
|
$ |
41,258 |
|
|
Accrued payroll and benefits |
|
7,918 |
|
|
|
11,971 |
|
|
Total current liabilities |
|
41,041 |
|
|
|
53,229 |
|
|
Other long-term liabilities |
|
4,946 |
|
|
|
10,766 |
|
|
Total liabilities |
|
45,987 |
|
|
|
63,995 |
|
|
Commitments and contingencies |
|
|
|
|||||
Stockholders’ equity: |
|
|
|
|||||
Preferred stock, |
|
— |
|
|
|
— |
|
|
Common stock, |
|
185 |
|
|
|
165 |
|
|
Additional paid-in capital |
|
1,124,625 |
|
|
|
1,094,353 |
|
|
Accumulated other comprehensive loss |
|
(2,955 |
) |
|
|
(3,042 |
) |
|
Accumulated deficit |
|
(1,088,413 |
) |
|
|
(1,043,923 |
) |
|
Total stockholders’ equity |
|
33,442 |
|
|
|
47,553 |
|
|
Total liabilities and stockholders’ equity |
$ |
79,429 |
|
|
$ |
111,548 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220811005222/en/
Managing Director, Westwicke ICR
858.356.5932
robert.uhl@westwicke.com
Chief Executive Officer
949.788.6700
InvestorRelations@sppirx.com
Source:
FAQ
What were Spectrum Pharmaceuticals' Q2 2022 financial results?
When is the PDUFA date for eflapegrastim?
What is the status of poziotinib's NDA?
How much cash does Spectrum Pharmaceuticals have?
