On May 6, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported financial results for the first quarter ended March 31, 2025, and provided a pipeline update on its clinical-stage investigational molecules across multiple common cancers (Press release, Arcus Biosciences, MAY 6, 2025, View Source [SID1234652568]).

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"Beginning with an oral presentation at ASCO (Free ASCO Whitepaper) for casdatifan in ccRCC, we expect to report a steady stream of data from ARC-20 throughout the remainder of 2025 and into 2026. We believe these data will support our robust development plan for casdatifan across multiple settings. This includes our Phase 3 trial, PEAK-1 in the IO-experienced setting, our clinical trial with AstraZeneca, which will combine casdatifan with their anti-PD-1/CTLA-4 bispecific antibody in the IO-naive setting, and three new cohorts in ARC-20 evaluating casdatifan in first- and second-line ccRCC," said Terry Rosen, Ph.D., chief executive officer of Arcus. "We believe that casdatifan has the potential to change the treatment paradigm for ccRCC, including the displacement of TKIs in earlier line settings, and our development plan is designed to establish casdatifan as the HIF-2a inhibitor of choice. Our balance sheet remains strong, and our operational plan and priorities are focused on ensuring that casdatifan is funded through its first Phase 3 readout."
Pipeline Highlights:

Casdatifan (HIF-2a inhibitor)
Casdatifan Updates:
•New clinical data from three monotherapy expansion cohorts in ARC-20 were presented in an oral session at the 2025 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium in February. At the time of data cut-off (DCO, January 3, 2025), the efficacy-evaluable population included a total of 87 patients with ccRCC who had received at least two prior lines of therapy, including both anti-PD-1 and a vascular endothelial growth factor receptor 2 (VEGFR)-TKI therapy. These data support the potential for casdatifan to be a best-in-class HIF-2a inhibitor for the treatment of ccRCC:
◦Despite limited follow-up, two of the cohorts exceeded 30% confirmed overall response rate (inclusive of one partial response confirmed after the DCO)
◦A 9.7-month median progression-free survival (PFS) was reached for the 50mg twice-daily casdatifan monotherapy cohort; median PFS was not yet reached for other cohorts
◦No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses.

Planned Data Readouts:
•June 2025: Safety and initial efficacy data for the ARC-20 cohort evaluating casdatifan plus cabozantinib in IO-experienced patients will be presented in an oral session at the ASCO (Free ASCO Whitepaper) Annual Meeting.
•Fall 2025: More mature data from the cohorts evaluating casdatifan monotherapy in patients who had progressed on both an anti-PD-1 and a TKI therapy.
•2026: More mature data from the casdatifan plus cabozantinib cohort and initial data from the new ARC-20 cohorts evaluating casdatifan in the first-line (1L) and IO-experienced settings.
Upcoming Study and Cohort Initiations:
•The PEAK-1 Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in IO-experienced ccRCC is expected to initiate in the second quarter of 2025.
•Shortly thereafter, Arcus and AstraZeneca expect to initiate a clinical study, part of AstraZeneca’s eVOLVE portfolio, evaluating casdatifan plus volrustomig, AstraZeneca’s investigational anti-PD-1/CTLA-4 bispecific antibody, in IO-naive ccRCC. This study will be operationalized by AstraZeneca.

Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)
•Overall survival data from the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) adenocarcinomas, are expected to be presented in the fall of 2025.
•The first Phase 3 data readout for domvanalimab plus zimberelimab will be from the ongoing Phase 3 study STAR-221, evaluating domvanalimab plus zimberelimab and chemotherapy in PD-L1 all-comer 1L metastatic upper GI adenocarcinomas and is expected in 2026.

CD73-Adenosine Axis: Quemliclustat (small-molecule CD73 inhibitor) and Etrumadenant (A2a/A2b receptor antagonist)

Quemliclustat:

•In the fourth quarter of 2024, Arcus initiated PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in first-line treatment of metastatic pancreatic cancer. PRISM-1 is recruiting rapidly, with enrollment completion expected by the end of 2025.
Etrumadenant:
•In March 2025, we engaged with the U.S. Food and Drug Administration (FDA) regarding promising results from the ARC-9 study evaluating etrumadenant in third-line metastatic colorectal cancer (mCRC); although the FDA’s feedback confirmed the potential for a registrational path for this program in third-line mCRC, based on our strategic priorities, we are not pursuing a Phase 3 study at this time.

Financial Results for First Quarter 2025:

•Cash, Cash Equivalents and Marketable Securities were $1.0 billion as of March 31, 2025, compared to $992 million as of December 31, 2024. The increase during the period is primarily due to the net proceeds from our underwritten offering in February 2025, partially offset by the use of cash in our research and development activities. We believe our cash, cash equivalents, and marketable securities, together with available facilities, will be sufficient to fund operations through the initial pivotal readouts for domvanalimab, quemliclustat and casdatifan, which include PEAK-1.
•Revenues were $28 million for the first quarter 2025, compared to $145 million for the same period in 2024. In the first quarter 2025, Arcus recognized $20 million in license and development services revenue related to the advancement of programs, as well as $8 million in other collaboration revenue primarily related to Gilead’s ongoing rights to access Arcus’s research and development pipeline in accordance with the Gilead collaboration agreement. Arcus expects to recognize GAAP revenue of between $75 million and $90 million for the full year 2025.
•Research and Development (R&D) Expenses were $122 million for the first quarter 2025, compared to $109 million for the same period in 2024. The net increase of $13 million was primarily driven by higher costs in our early-stage development and preclinical program activities, driven by higher enrollment in our Phase 2 studies. The overall increase was partially offset by reduced spend in our late-stage development activities due to lower manufacturing costs driven by the timing of manufacturing activities. Non-cash stock-based compensation expense was $8 million for the first quarter 2025, compared to $10 million for the same period in 2024. For the first quarters 2025 and 2024, Arcus recognized gross reimbursements of $38 million and $37 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.
•General and Administrative (G&A) Expenses were $28 million for the first quarter 2025, compared to $32 million for the same period in 2024. The decrease was primarily driven by the costs incurred to obtain the Third Gilead Agreement Amendment in 2024. Non-cash stock-based compensation expense was $8 million for the first quarter 2025, compared to $10 million for the same period in 2024.
•Net Loss was $112 million for the first quarter 2025, compared to $4 million for the same period in 2024.

Conference Call Information:

Arcus will host a conference call and webcast today, May 6th, at 1:30 PM PT / 4:30 PM ET to discuss its first-quarter 2025 financial results and pipeline updates. To access the call, please dial +1 (404) 975-4839 (local) or +1 (833) 470-1428 (toll-free), using Access Code: 762544. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event.

Arcus Ongoing and Announced Clinical Studies:
Trial Name
Arms
Setting
Status
NCT No.
Kidney Cancer
PEAK-1
cas + cabo vs. cabo
Post-IO ccRCC
Planned Phase 3
TBD
AstraZeneca Collaboration (part of eVOLVE portfolio)
cas + volru
2L+ IO-Naive ccRCC
Planned
TBD
ARC-20
cas, cas + cabo, cas +zim
1L, 2L, and 2L+ Cancer Patients/ccRCC
Ongoing Phase 1/1b
NCT05536141
Upper Gastrointestinal Cancers
STAR-221
dom + zim + chemo vs. nivo + chemo
1L Gastric, GEJ and EAC
Ongoing Registrational Phase 3
NCT05568095
EDGE-Gastric (ARC-21)
dom +/- zim +/- chemo
1L/2L Upper GI Malignancies
Ongoing
Randomized Phase 2
NCT05329766
Lung Cancer
STAR-121
dom + zim + chemo vs. pembro + chemo
1L NSCLC (PD-L1 all-comers)
Ongoing Registrational Phase 3
NCT05502237
PACIFIC-8
dom + durva vs. durva
Unresectable Stage 3 NSCLC
Ongoing Registrational Phase 3
NCT05211895
EDGE-Lung
dom +/- zim +/- quemli +/- chemo
1L/2L NSCLC (lung cancer platform study)
Ongoing Randomized Phase 2
NCT05676931
VELOCITY-Lung
dom +/- zim +/- sacituzumab govitecan-hziy or other combos
1L/2L NSCLC (lung cancer platform study)
Ongoing Randomized Phase 2
NCT05633667
Pancreatic Cancer
PRISM-1
quemli + gem/nab-pac vs. gem/nab-pac
1L PDAC
Ongoing Randomized Phase 3
NCT06608927
ARC-8
quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac
1L PDAC
Ongoing Randomized Phase 1/1b
NCT04104672
Other
ARC-25
AB598
Gastric Cancer
Ongoing Phase 1
NCT05891171
ARC-27
AB801
NSCLC
Ongoing Phase 1
NCT06120075

cabo: cabozantinib; cas: casdatifan; ccRCC: clear cell renal cell carcinoma; dom: domvanalimab; durva: durvalumab; EAC: esophageal adenocarcinoma; GEJ: gastroesophageal junction; gem/nab-pac: gemcitabine/nab-paclitaxel; GI: gastrointestinal; IO: immunotherapy; nivo: nivolumab; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma; pembro: pembrolizumab; quemli: quemliclustat; volru: volrustomig; zim: zimberelimab.

On May 6, 2025 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will participate at two upcoming investor conferences in May (Press release, Neurocrine Biosciences, MAY 6, 2025, View Source [SID1234652584]).

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Chief Executive Officer Kyle Gano and Vice-President of Investor Relations Todd Tushla will present at the BofA Securities 2025 Health Care Conference on Tuesday, May 13, 2025 at 11:20 AM Pacific Time in Las Vegas.
Chief Financial Officer Matt Abernethy and Chief Commercial Officer Eric Benevich will present at the RBCCM Global Healthcare Conference on Tuesday, May 20, 2025 at 11:30 AM Eastern Time in New York.

The live webcasts can be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcasts will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On May 6, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported a business update and announced financial results for the first quarter ended March 31, 2025 (Press release, Cogent Biosciences, MAY 6, 2025, View Source [SID1234652601]).

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"The first quarter of 2025 was very productive for Cogent as our team focused on executing across our portfolio in preparation for three transformative data readouts this year. We look forward to reporting top-line results from our registration-directed SUMMIT trial with bezuclastinib in patients with nonadvanced systemic mastocytosis in July, followed later in the year with top-line results from our APEX and PEAK trials," said Andrew Robbins, the Company’s President and Chief Executive Officer. "While we are preparing for a potential launch of bezuclastinib in 2026, we are also very proud of the progress we have made with our early-stage pipeline, including presentations from four distinct programs recently at the annual AACR (Free AACR Whitepaper) conference."

Recent Business Highlights

Announced expanded clinical results from the Open Label Extension (OLE) portion of the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2025 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting.
Bezuclastinib showed a 65% mean improvement in Total Symptom Score (TSS) at 48 weeks, including 88% of patients achieving at least a 50% reduction in TSS.
The safety profile for bezuclastinib remains favorable, with adverse events reported primarily as low-grade and reversible. No treatment-related bleeding or cognitive impairment was observed. The most common treatment-related adverse events were hair discoloration and transient elevations in liver transaminases. All cases of elevated transaminases were asymptomatic and fully reversible.
Presented updated preclinical data from the company’s KRAS, PI3Kα, FGFR2/3 and ErbB2 candidates at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
Upcoming Milestones

Announce top-line results from SUMMIT in July 2025. SUMMIT is a registration-directed, randomized, double-blind, placebo-controlled, global, multicenter, clinical trial of bezuclastinib in patients with NonAdvSM.
Announce top-line results from APEX in the second half of 2025. APEX is a registration-directed, global, open-label trial in patients with advanced systemic mastocytosis (AdvSM).
Announce top-line results from PEAK by the end of 2025. PEAK is a global, blinded, randomized Phase 3 clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant gastrointestinal stromal tumors (GIST).
First Quarter 2025 Financial Results

Cash and Cash Equivalents: As of March 31, 2025, cash, cash equivalents and marketable securities were $245.7 million. During the quarter, the Company sold shares under the Company’s at-the-market (ATM) stock offering for net proceeds of $24.3 million and incurred a non-recurring payment of $9.6 million related to annual performance-based bonus compensation. Based on its current plans, the Company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into late 2026, including through clinical readouts from ongoing SUMMIT, PEAK, and APEX registration-directed trials.

R&D Expenses: Research and development expenses were $63.0 million for the first quarter of 2025 compared to $52.7 million for the first quarter of 2024. The increase was primarily due to costs incurred to support our on-going SUMMIT, PEAK and APEX clinical trials and to the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $5.3 million for the first quarter of 2025 as compared to $4.4 million for the first quarter of 2024.

G&A Expenses: General and administrative expenses were $11.9 million for the first quarter of 2025 compared to $9.7 million for the first quarter of 2024. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $4.8 million for the first quarter of 2025 as compared to $5.0 million for the first quarter of 2024.

Net Loss: Net loss was $72.0 million for the first quarter of 2025 compared to a net loss of $58.3 million for the first quarter of 2024.

On May 6, 2025 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported first quarter 2025 financial results and provided an update on corporate and pipeline progress across the company’s hematology and genetic disease franchises (Press release, Beam Therapeutics, MAY 6, 2025, View Source [SID1234652569]).

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"Beam has had a tremendous start to what we anticipate will be a transformative year. In March, we achieved a historic milestone with BEAM-302, delivering the first-ever clinical genetic correction of a disease-causing mutation for alpha-1 antitrypsin deficiency. Building on this momentum, we have swiftly advanced the program—initiating the fourth cohort of Part A of the Phase 1/2 BEAM-302 study and securing U.S. FDA clearance for our investigational new drug application, positioning us for continued rapid progress," said John Evans, chief executive officer of Beam. "Additionally, we recently dosed the first patient in our second in vivo program, BEAM-301, a potential treatment for glycogen storage disease type Ia. In our hematology franchise, we are preparing to share updated clinical data from the BEACON Phase 1/2 trial of BEAM-101 in sickle cell disease at EHA (Free EHA Whitepaper) in June and remain on track to complete dosing for 30 patients by mid-year. This significant clinical progress is supported by our strong financial foundation, further reinforced by our recent $500 million financing, which extends our projected cash runway into 2028."

First Quarter 2025 and Recent Progress

•
Recently, the first patient was dosed in the U.S.-based Phase 1/2 clinical trial evaluating BEAM-301 as a potential treatment for patients with glycogen storage disease type Ia (GSDIa), an autosomal recessive disorder that disrupts glucose homeostasis. BEAM-301 is an investigational in vivo base editing treatment designed to correct the R83C mutation, the most common disease-causing mutation that results in the most severe form of GSDIa.
•
Clinical data from the BEACON Phase 1/2 clinical trial of BEAM-101, an investigational genetically modified cell therapy for the treatment of sickle cell disease (SCD), have been accepted for presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress, taking place in Milan from June 12-15, 2025.
•
In March, the United States (U.S.) Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for BEAM-302 for the treatment of alpha-1 antitrypsin deficiency (AATD), enabling the company to begin activating sites in the U.S. for its ongoing Phase 1/2 trial.
•
Also in March, the company announced positive initial safety and efficacy data from the Phase 1/2 trial of BEAM-302, establishing clinical proof of concept for a potential treatment addressing AATD and for in vivo base editing. Preliminary results from the first three single-ascending dose cohorts in Part A of the trial demonstrated that BEAM-302 was well tolerated, with single doses of BEAM-302 leading to durable, dose-dependent correction of the disease-causing mutation. In April, an encore of the data was presented at the 2025 Alpha-1 Foundation 7th Global Research Conference and 10th Patient Congress, alongside updated biomarker data from the 60 mg cohort that provided further evidence of BEAM-302’s clinical profile. Since reporting the data, Beam has initiated dosing in the fourth cohort of Part A, evaluating 75 mg of BEAM-302.
•
In conjunction with the BEAM-302 initial data, Beam completed a $500 million oversubscribed, registered direct financing, enabling the company to fund its anticipated operating expenses and capital expenditure requirements into 2028.
Key Anticipated Milestones

Liver-targeted Genetic Disease Franchise

•
Beam plans to continue the dose-escalation portion of Part A of the ongoing BEAM-302 Phase 1/2 clinical trial and expects to report further data at a medical conference in the second half of 2025.
•
The company plans to dose the first patient in Part B of the ongoing BEAM-302 Phase 1/2 clinical trial, which will include AATD patients with mild to moderate liver disease, in the second half of 2025.
•
The company plans to continue dosing in the Phase 1/2 clinical trial of BEAM-301 in GSDIa.
Hematology Franchise

•
Beam expects to dose 30 patients in the BEACON Phase 1/2 clinical trial of BEAM-101 in adults with severe SCD by mid-2025.
•
The company also plans to present updated data from the BEACON Phase 1/2 trial during EHA (Free EHA Whitepaper) 2025 in June.
•
The company expects to initiate a Phase 1 healthy volunteer clinical trial of BEAM-103, the ESCAPE monoclonal antibody, by the end of 2025.
First Quarter 2025 Financial Results

•
Cash Position: Cash, cash equivalents and marketable securities were $1.2 billion as of March 31, 2025, compared to $850.7 billion as of December 31, 2024.
•
Research & Development (R&D) Expenses: R&D expenses were $98.8 million for the first quarter of 2025, compared to $84.8 million for the first quarter of 2024.
•
General & Administrative (G&A) Expenses: G&A expenses were $27.9 million for the first quarter of 2025, compared to $26.7 million for the first quarter of 2024.
•
Net Income (Loss): Net loss was $109.3 million, or $1.24 per share, for the first quarter of 2025, compared to $98.7 million, or $1.21 per share, for the first quarter of 2024.
Cash Runway

Beam expects that its cash, cash equivalents and marketable securities as of March 31, 2025, including net proceeds from the recent $500 million financing, will enable the company to fund its anticipated operating expenses and capital expenditure requirements into 2028. This expectation includes funding directed toward reaching each of the key anticipated milestones for BEAM-101, ESCAPE, BEAM-301 and BEAM-302 described above.

On May 6, 2025 NuCana plc (NASDAQ: NCNA), a clinical-stage biopharmaceutical company that focuses on significantly improving treatment outcomes for patients with cancer, reported that it has priced a registered direct offering consisting of 10,845,985 American Depository Shares, or ADSs, (or pre-funded warrants in lieu thereof) with each ADS (or pre-funded warrant) accompanied by (i) a Series A warrant to purchase one (1) ADS at an initial exercise price of $0.8068 per share and (ii) a Series B Warrant to purchase one (1) ADS at an initial exercise price of $1.61 per share (Press release, Nucana, MAY 6, 2025, View Source [SID1234652585]). The combined public offering price of each ADS together with the accompanying Series A and Series B Warrants is $0.6454, and the combined offering price of each pre-funded warrant together with the accompanying Series A and Series B warrants is $0.6454, minus the United States dollar equivalent of £0.01, based on the exchange rate on the date of pricing. The gross proceeds of the offering are expected to be approximately $7 million before deducting placement agent fees and offering expenses and are expected to be used to fund activities relating to the advancement of our drug discovery and development programs, and for other general corporate purposes, including, but not limited to, working capital, capital expenditures, investments, acquisitions, should we choose to pursue any, and collaborations. The closing of the offering is expected to occur on or about May 7, 2025, subject to the satisfaction of customary closing conditions.

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Laidlaw & Company (UK) Ltd. is acting as the sole placement agent for the offering.

This registered offering is being made by the Company pursuant to a registration statement on Form F-1 (File No. 333-286716), which was declared effective by the United States Securities and Exchange Commission ("SEC") on May 5, 2025. The securities may only be offered by means of a prospectus. Copies of the prospectus may be obtained, when available, at the SEC’s website at www.sec.gov or from Laidlaw & Company (UK) Ltd., 521 5th Avenue, 12th Floor, New York, NY 10175, or by telephone at (212) 953-4900, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall 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 the registration or qualification under the securities laws of any such state or other jurisdiction.