Item 2.02 Results of Operations and Financial Condition.
On
The information in this Item 2.02 of Form 8-K and the information incorporated by reference herein, including Exhibit 99.1 attached hereto, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events. Financial Results
On
The Company anticipates global net product revenues for Rubraca in the range of
The Company expects research and development expenses to be lower in the full year 2022 compared to 2021. The Company continues to expect selling, general and administrative expenses to decrease in the full year 2022 compared to 2021.
The Company anticipates net loss for the quarter ended
The Company had
As of
Net cash used in the Company's operating activities is anticipated to be in the
range of
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Pipeline Highlights
Three Anticipated Rubraca Phase 3 studies on Track for 2022 Readouts
Top-line data from the ATHENA Phase 3 study in first-line maintenance treatment ovarian cancer setting evaluating Rubraca monotherapy versus placebo are expected in the first quarter of 2022 based on event-based projections. Data from the combination arm of Rubraca plus Opdivo® (nivolumab) versus Rubraca monotherapy are expected in the second half of 2022 based on protocol-defined assumptions.
Top-line data from the TRITON3 trial, which is expected to serve as the confirmatory study for Rubraca's approval in metastatic castration-resistant prostate cancer (mCRPC) as well as a potential second-line label expansion, are expected in the second quarter of 2022. TRITON3 is a Phase 3 study evaluating Rubraca versus physician's choice of chemotherapy or second-line androgen deprivation therapy in patients with mCRPC with BRCA and ataxia-telangiectasia mutated (ATM) protein mutations.
The three anticipated data readouts, ATHENA monotherapy, ATHENA combination and TRITON3, provide the potential to reach larger patient populations in earlier lines of therapy for ovarian and prostate cancers, in which Rubraca is currently approved in later-line indications. The timing for each data readout is contingent upon the occurrence of the protocol-specified progression-free survival (PFS) events.
LuMIERE Phase 1/2 Study of FAP-2286 Enrolling Patients with FAP-Positive Solid Tumors into Phase 1; Initial Phase 1 LuMIERE Data Expected in 2022
FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) to enter clinical development and is the lead candidate in the Company's TRT development program. The ongoing Phase 1 portion of the LuMIERE study, for which enrollment in the second dose cohort is currently ongoing, is evaluating the safety of the FAP-targeting investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be used as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment in LuMIERE. The first presentations of Phase 1 data from LuMIERE are expected at medical meetings in 2022. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types and are expected to initiate in 2022.
Nonclinical data evaluating FAP expression across a variety of solid tumor types were presented at AACR-NCI-EORTC in October. High FAP expression was observed in multiple indications, including pancreatic ductal adenocarcinoma, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous NSCLC, and head and neck cancers as well as in cancers of unknown primary. In these tumor types, high FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. The analysis also demonstrated that in most tumor types, FAP expression was predominantly localized to cancer-associated fibroblasts (CAFs) surrounding the tumor cells and integrated into the tumor microenvironment. In addition, in cancers of mesenchymal origin including sarcoma and mesothelioma, expression was observed in tumor cells in addition to CAFs. These data support the investigation of FAP-2286 in multiple tumor types in the planned Phase 2 expansion cohorts of LuMIERE. Additional presentations of nonclinical data are anticipated at medical meetings over the next few quarters in 2022.
Impact of COVID-19 Pandemic
The Company's ability to generate product revenues for the three and twelve
months ended
This curtailment of and/or limited physical access has decreased sales and
marketing expenses during the three and twelve months ended
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The Company did not see material disruption to its clinical trials as a result
of the COVID-19 pandemic for the three and twelve months ended
The trading prices for the Company's common stock and of other biopharmaceutical companies have been highly volatile as a result of the coronavirus pandemic. As a result of this volatility and uncertainties regarding future impact of COVID-19 on the Company's business and operations, the Company may face difficulties raising capital or may only be able to raise capital on unfavorable terms.
Liquidity
The Company has incurred significant net losses since inception and has relied
on its ability to fund its operations through debt and equity financings. The
Company expects operating losses and negative cash flows to continue for the
foreseeable future even with Rubraca now generating revenues. Rubraca revenues
have not been consistent in prior quarters, mainly as a result of the impact of
COVID-19 and competition from other products on the market, including the impact
on second-line maintenance that may result from an increase in first-line
maintenance treatment of ovarian cancer, which has made forecasting revenues
difficult. In addition to other factors, future Rubraca revenues will depend, in
part, on the timing and extent of any recovery from the impacts of COVID-19,
with any such recovery expected to take several quarters to have a meaningful
impact on the Company's financial results. Until the Company can generate a
sufficient amount of Rubraca revenues to finance its cash requirements, which
the Company does not expect in the foreseeable future and which the Company may
never do in sufficient amounts, the Company expects to finance its operating
plan through a combination of public or private equity or debt offerings,
collaborations, strategic alliances and other similar licensing arrangements in
both the short term and the long term. In the near term, the Company believes
there is some flexibility within its operating plan, particularly with managing
certain discretionary expenses, to adjust to variations in its expected Rubraca
revenues and the availability and timing of potential sources of financings to
meet its working capital requirements. However, based on its current cash, cash
equivalents and liquidity available under its financing agreement related to the
ATHENA trial, together with current estimates for revenues generated by sales of
Rubraca, the Company will need to raise additional capital in the near term in
order to fund its operating plan for the next 12 months. The Company currently
has capacity to issue approximately
In addition, in order to continue to raise capital through the sale of equity securities beyond the shares already reserved for issuance under the Company's ATM Program, the Company will need its stockholders, at the 2022 Annual Meeting of Stockholders, to consider again and to approve a proposal to amend the Company's certificate of incorporation to increase the number of shares of common stock that the Company is authorized to issue. The Company cannot be certain that its stockholders will approve such a proposal. In the event the Company's stockholders do not approve such a proposal, the Company's ability to raise capital to fund its operations beyond the next 12 months will be significantly limited and the Company will need to consider potentially more costly sources of funding, potentially through incurring further indebtedness or entering into strategic partnerships or licensing arrangements for one or more of its products or product candidates in which it may have to give up certain of its future commercialization rights for interim funding. The Company cannot be certain that such other sources of funding will be available to it or on acceptable terms or in sufficient amounts to meet its requirements.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits: 99.1 Press Release datedJanuary 10, 2022 . 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
To the extent that statements contained in this current report are not
descriptions of historical facts regarding the Company, they are forward-looking
statements reflecting the current beliefs and expectations of management made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Examples of forward-looking statements contained in this
press release include, among others, statements regarding the Company's
preliminary estimates of fourth quarter and fiscal year 2021 revenues, net loss
and cash used in operating activities, the Company's expectations for commercial
launches, availability of study data and submission of regulatory filings and
statements of its intentions and expectations for its development and discovery
programs, including the timing and pace of pre-clinical development, plans for
and expected timing and pace of clinical development, plans for additional
applications of the FAP-2286 peptide, the potential impact of COVID-19 on the
Company's business and clinical trials and the Company's ability to raise
additional capital to fund its operating plan. Such forward-looking statements
involve substantial risks and uncertainties that could cause the Company's
future results, performance or achievements to differ significantly from that
expressed or implied by the forward-looking statements. Such risks and
uncertainties include, among others, the impacts of the COVID-19 pandemic and
disruption related to efforts to mitigate its spread on the Company's business,
results of operation or financial condition, including impacts on the vendors or
distribution channels in it's supply chain, impacts on its contract
manufacturers ability to continue to manufacture its products, impacts on its
ability to continue its development activities, impacts on the conduct of its
clinical trials, including with respect to enrollment rates, availability of
investigators and clinical trial sites or monitoring of data and impact on the
ability and timing of the Company's field personnel to conduct their activities
with health care providers, the uncertainties inherent in the effect the
Company's future revenues or expenses may have on its cash and liquidity
position, the market potential of the Company's approved drug, including the
performance of the Company's sales and marketing efforts, the success of
competing drugs and therapeutic approaches, changes in gross-to-net or free drug
provided through the Company's patient assistance program, the availability of
reimbursement and insurance coverage, the timing of availability of data from
its clinical trials, the uncertainties inherent in actions or decisions by
the FDA, the EMA or other regulatory authorities regarding whether to accept or
approve drug applications that may be filed, including delays or denials of
regulatory approvals, clearances or authorizations for applications, as well as
their decisions regarding drug labeling, reimbursement and pricing. Furthermore,
the Company is in the process of finalizing its financial results for the fourth
quarter and fiscal year 2021, and therefore the Company's finalized and audited
results and final analysis of those results are not yet available. The
preliminary expectations regarding 2021 revenues, net loss, cash used in
operating activities and year-end cash and cash equivalents are subject to
management's review and actual results could differ from management's
expectations. The actual results are also subject to audit by the Company's
independent registered public accounting firm and no assurance is given by the
Company's independent registered public accounting firm on such preliminary
expectations. You should not draw any conclusions as to any other financial
results as of and for the year ended
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