On November 5, 2020 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended September 30, 2020, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for the rest of the year (Press release, Clovis Oncology, NOV 5, 2020, View Source [SID1234570013]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased that third quarter revenues for Rubraca grew slightly over the same period in 2019, despite a very challenging sales environment caused by COVID-19, which has severely limited oncology patient visits and cancer diagnoses. In addition, oncology practices have substantially limited traditional in-person sales calls – a trend that we see accelerating – and physicians increasingly prefer digital communications and virtual peer-to-peer interactions. In response to this evolving U.S. oncology market, we are shifting to a hybrid commercial strategy to support these preferences. This new strategy incorporates more targeted in-person promotion, online resources for prescribers customized to their practices and new approaches to peer-to-peer interactions. We believe this hybrid strategy will increase awareness and interest in Rubraca. We have undertaken this change with the goal of returning to growth as rapidly as we can, despite cancer diagnoses and cancer patient visits currently remaining lower than pre-COVID-19," said Patrick J. Mahaffy, President and CEO of Clovis Oncology.

"We also remain focused on our growing pipeline activities and in 2021, we anticipate multiple meaningful clinical, development and regulatory milestones. For Rubraca, we anticipate data from the ATHENA monotherapy arm, and pending data, a potential sNDA filing for the LODESTAR pan-tumor study in the second half of 2021. Interim updates from the LIO-1 study of lucitanib and Opdivo in combination are anticipated in 2021. Following allowance of the IND filings for our peptide-targeted radiotherapeutic candidate, FAP-2286, planned for submission this quarter, we plan to initiate a robust clinical development program in early 2021," Mr. Mahaffy continued.

Third Quarter 2020 Financial Results

Clovis reported net product revenue for Rubraca of $38.8 million for the third quarter of 2020, which included U.S. product revenue of $33.9 million and ex-U.S. product revenue of $4.9 million, compared to net product revenue for Q3 2019 of $37.6 million, which included U.S. net product revenue of $36.5 million and ex-U.S. net product revenue of $1.1 million.

Clovis reported net product revenue for Rubraca of $121.2 million for the nine months ended September 30, 2020, which included U.S. product revenue of $109.8 million and ex-U.S. product revenue of $11.4 million, compared to net product revenue for same period in 2019 of $103.7 million, which included U.S. net product revenue of $101.1 million and ex-U.S. net product revenue of $2.6 million.

Clovis Oncology expects global net product revenue for the fourth quarter 2020 to be in a range of $38 million to $40 million. The effects of COVID-19 on future sales are difficult to predict, especially with the increase in COVID-19 cases in the U.S. and Europe.

Research and development expenses totaled $62.9 million for Q3 2020 and $201.0 million for the first nine months of 2020, compared to $77.9 million and $210.7 million for the comparable periods in 2019. Research and development expenses decreased for the third quarter and the first nine months of 2020 compared to the same periods in the prior year due primarily to lower spending on Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to full year 2020.

Selling, general and administrative expenses totaled $38.6 million for Q3 2020 and $123.1 million for the first nine months of 2020, compared to $41.8 million and $137.6 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the third quarter and first nine months of 2020 compared to the same period in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts.

Clovis reported a net loss for the third quarter of 2020 of $78.7 million, or ($0.89) per share, and a net loss of $270.3 million, or ($3.37) per share, for the first nine months of 2020. Net loss for Q3 2019 was $94.1 million, or ($1.72) per share, and $300.9 million, or a net loss of ($5.62) per share, for the first nine months of 2019. Net loss for Q3 and the first nine months of 2020 included share-based compensation expense of $12.5 million and $38.8 million, compared to $14.0 million and $41.7 million for the comparable periods of 2019.

Clovis had $224.7 million in cash and cash equivalents as of September 30, 2020.

As of September 30, 2020, the Company had drawn approximately $85 million under the TPG ATHENA clinical trial financing and had up to $90 million available to draw under the agreement to fund the expenses of the ATHENA trial through Q3 2022.

Based on the Company’s anticipated revenues, spending, available financing sources and existing cash and cash equivalents, the Company believes it has sufficient cash and cash equivalents to fund its operating plan into early 2022, after taking into account any cash repayment (unless refinanced earlier) of the remaining $64.42 million aggregate principal amount of the 2.50% convertible notes, at their maturity in September 2021. Assuming the completion of the offering of $50 million of convertible notes announced today, the additional cash proceeds are anticipated to fund the Company’s operating plan into early 2023.

Net cash used in operating activities was $54.3 million for the third quarter of 2020, down from $57.0 million reported in the third quarter of 2019. Similarly, net cash used in operating activities for the first nine months of 2020 was $196.7 million, compared with $253.5 million for the first nine months of 2019.

Cash burn in Q3 2020 was $37.7 million, which represents a 25 percent sequential decrease from the Q2 2020 cash burn of $50.1 million. Borrowings under the TPG ATHENA financing provided $16.6 million in cash in Q3 2020. Cash burn in the first nine months of 2020 was $154.7 million.

Restructured U.S. Commercial Organization

The COVID-19 pandemic has accelerated a preference by oncology practices for more digital programming, including digital peer-to-peer interactions and reduced in-person promotion. In order to meet these changing preferences, the Company is adopting a hybrid commercial strategy combining increased digital promotional activities, greater online resources and more peer-to-peer interactions with reduced and more targeted in-person promotion. Accordingly, new tools and performance indicators based on this hybrid approach are being rolled out during the fourth quarter, and the U.S. commercial organization has been reduced in size by approximately 45 employees. Despite increased investment in digital promotion, we anticipate an effect of adopting this hybrid model will result in annual cost-savings of approximately $10 million. The Company is adopting this strategy in order to better reach customers in the way they want to be reached with the goal of returning to growth, especially as the ongoing impact of COVID-19 is reduced.

FDA-approved Companion Diagnostic to Identify Eligible mCRPC Patients Added to Rubraca U.S. Label

In late August, the U.S. FDA approved the FoundationOne Liquid CDx, Foundation Medicine’s comprehensive liquid biopsy test for all solid tumors with multiple companion diagnostic indications, including for Rubraca. It is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies, including Rubraca. In early October, the companion diagnostic for Rubraca in mCRPC was added to the Rubraca U.S. label.

These events follow the U.S. FDA’s May 2020 approval of Rubraca for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated mCRPC who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this indication under accelerated approval based on objective response rate and duration of response data from the multi-center, single arm TRITON2 clinical trial.

Data from the TRITON2 study of Rubraca for the treatment of mCRPC harboring BRCA1/2 mutations were published online in the Journal of Clinical Oncology during the quarter. These results supported the May approval and provide additional detail for physicians about the study and about Rubraca as a treatment option for eligible men with mCRPC and a deleterious BRCA1/2 mutation.

Initial Presentations for Lucitanib and Rucaparib Combinations and Preclinical Data for FAP-2286 at Medical Meetings

Six e-posters for Clovis’ three portfolio compounds were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 in September. These included the following:

Initial data from the Phase 1b part of the LIO-1 trial of lucitanib combined with Opdivo (nivolumab) in advanced metastatic solid tumors which identified a recommended Phase 2 dose and showed promising signs of antitumor activity; also, a Trials In Progress e-poster describing the Phase 2 study currently enrolling patients.
The first presentation of preclinical data for FAP-2286, a novel peptide-targeted radionuclide therapy (PTRT), showed the compound potently and selectively binds fibroblast activation protein (FAP); in addition, compelling anti-tumor activity was observed in FAP-expressing tumor models.
New data analyses from pivotal Rubraca studies ARIEL3 and TRITON2 further characterized its safety profile in recurrent ovarian cancer and metastatic castration-resistant prostate cancer (mCRPC), respectively.
Encouraging initial data from the SEASTAR study evaluating Rubraca in combination with Trodelvy (sacituzumab govitecan-hziy).
In addition, in an oral plenary session at the International Gynecologic Cancer Society (IGCS) Digital Annual Global Meeting in September, data from an exploratory analysis of the ARIEL3 clinical study evaluating Rubraca as maintenance treatment in recurrent ovarian cancer were presented. The findings demonstrate that rucaparib maintenance treatment can lead to a clinically meaningful delay in starting subsequent therapy and lasting clinical benefits in patients with BRCA1- or BRCA2-mutant ovarian cancer.

The data described here are available online at www.clovisoncology.com/pipeline/scientificpresentations.

Lucitanib Combination Studies Underway

The Phase 2 portion of LIO-1 trial evaluating lucitanib and Opdivo in combination in advanced solid tumors (Phase 1b) and gynecologic cancers (Phase 2) is open for enrollment and the first patient was treated in August. Clovis intends to submit updated interim data from the LIO-1 study for presentation at a 2021 medical meeting.

FAP-2286 and Radionuclide Therapy Development Program

Clovis intends to submit two Investigational New Drug (IND) applications for FAP-2286 for use as imaging and treatment agents respectively. Following allowance of the INDs by the U.S. FDA, Clovis will initiate a Phase 1 study to determine the dose and tolerability of the FAP-targeting therapeutic agent, with expansion cohorts planned in multiple tumor types. The FAP-targeting imaging agent will be utilized to identify tumors that contain FAP for treatment in the Phase 1 study.

Conference Call Details

Clovis will hold a conference call to discuss Q3 2020 results this morning, November 5, at 8:30am ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 2999168.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on a FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

About Lucitanib

Lucitanib is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis holds U.S. and global rights for FAP-2286 excluding Europe.

FAP-2286 is an unlicensed medical product.

On November 5, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported that Jeffrey Eisenberg, Chief Executive Officer of Xenetic will present at the H.C. Wainwright 6th Annual Israel Conference on Tuesday, November 12, 2020 at 8:00 AM EST (Press release, Xenetic Biosciences, NOV 5, 2020, View Source [SID1234570012]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition to the presentation, management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

A live video webcast of the presentation will be available on the IR Calendar page of the Investors section of the Company’s website (xeneticbio.com). The video webcast replay will be made available two hours following the event and will be archived for 90 days.

On November 5, 2020 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported financial results for the third quarter ended September 30, 2020 and provided corporate updates (Press release, Selecta Biosciences, NOV 5, 2020, View Source [SID1234570011]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This past quarter has been productive for our team as we have continued to progress our clinical programs," said Carsten Brunn, Ph.D., President and CEO of Selecta. "We reported topline data from the Phase 2 COMPARE trial of SEL-212 which demonstrated the potential of our ImmTOR platform when combined with a highly immunogenic enzyme, and we commenced the Phase 3 DISSOLVE program in partnership with Sobi. We look forward to continuing to build our pipeline with our gene therapy programs in MMA and OTC deficiency, and our second enzyme program in IgA nephropathy. Our strategy is focused on leveraging ImmTOR to amplify the efficacy of biologic therapies and restore self-tolerance in autoimmune diseases."

Recent Highlights and Anticipated Upcoming Milestones:

Two Key Clinical Milestones for SEL-212: In September, Selecta and Sobi commenced the Phase 3 clinical program, known as DISSOLVE, with Selecta running the program and Sobi reimbursing Selecta for costs associated with the program. The DISSOLVE clinical program consists of two double-blind, placebo-controlled trials of SEL-212 (NCT04513366) in which SEL-212 will be evaluated at two doses of ImmTOR (0.1 mg/kg and 0.15 mg/kg), and one dose of pegadricase (0.2 mg/kg) in both studies. Each trial will aim to enroll 105 patients (35 at each dose level and 35 on placebo). In DISSOLVE I, safety and efficacy will be evaluated at six months and will have a six-month extension. DISSOLVE II will assess safety and efficacy at only the six-month time point, with no extension. The primary endpoint in both studies is serum uric acid levels (SUA) less than 6 mg/dL at six months, a well-validated measure of disease severity in chronic refractory gout. Topline data from the DISSOLVE program is expected in the second half of 2022. Also in September, the Company reported topline results from the Phase 2 COMPARE clinical trial in which a once-monthly dose of SEL-212 (ImmTOR + pegadricase) was compared to biweekly doses of pegloticase. Sobi has in-licensed SEL-212 and assumes responsibility for all development (excluding DISSOLVE, which is run by Selecta and funded by Sobi), regulatory, and commercial activities, and expenses in all markets outside China. Selecta is eligible to receive potential development, regulatory, and commercial milestone payments of up to $630 million, and tiered double-digit royalties on net sales.

Granted Rare Pediatric Disease Designation with AskBio for Gene Therapy for Methylmalonic Acidemia: Selecta and AskBio have received Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) to develop MMA-101 in combination with ImmTOR for the treatment of isolated methylmalonic acidemia (MMA) due to methylmalonyl-CoA mutase (MMUT) gene mutations. Selecta and AskBio expect to commence a Phase 1 clinical trial in this program in the first half of 2021, with preliminary data expected by the end of 2021.

Entered into Research License and Option Agreement with IGAN Biosciences for the Use of ImmTOR in IgA Nephropathy: In October, Selecta and IGAN Biosciences reached an agreement which provides Selecta with the option to an exclusive license for the rights to develop and commercialize the ImmTOR platform in combination with IGAN’s immunoglobulin A (IgA) protease for the treatment of IgA nephropathy (IgAN). Selecta intends to submit its Investigational New Drug Application (IND) for IgA nephropathy by the end of 2021. IgA nephropathy is characterized by deposition of galactose-deficient IgA1 immunoglobulin in the glomerular mesangium and is a leading contributor to development of chronic kidney disease and renal failure. There are no approved therapies for the treatment of IgAN.
Third Quarter 2020 Financial Results:

Cash Position: Selecta had $147.6 million in cash, cash equivalents, and restricted cash as of September 30, 2020, which compares to cash, cash equivalents, and restricted cash of $91.6 million as of December 31, 2019. Selecta believes its available cash, cash equivalents, and restricted cash as of September 30, 2020 will enable Selecta to fund operating expenses and capital expenditure requirements into the first quarter of 2023.

• Net cash provided by operating activities was $42.1 million for the nine months ended September 30, 2020, as compared to $38.6 million used for the same period in 2019.
Revenue: Revenue recognition for the third quarter 2020 was $4.6 million. During the three months ended September 30, 2020, we recognized $4.3 million under the license agreement with Sobi resulting from the shipment of clinical supply and the reimbursement of costs incurred for the Phase 3 DISSOLVE clinical program and $0.3 million for shipments under the collaboration agreement with Sarepta. During the three months ended September 30, 2019, Selecta did not recognize revenue.
Research and Development Expenses: Research and development expenses for the third quarter 2020 were $14.0 million, which compares with $8.1 million for the same period in 2019. The increase in cost was primarily the result of the initiation of the Phase 3 DISSOLVE clinical program. These costs are subject to the cost reimbursement arrangement under the license with Sobi. The increase in expense was also the result of the completion of its Phase 2 COMPARE trial for SEL-212 and for the AskBio Collaboration.

General and Administrative Expenses: General and administrative expenses for the third quarter 2020 were $4.4 million, which compares with $3.7 million for the same period in 2019. The increase in costs was the result of expenses incurred for facilities, legal and professional fees offset by decreased travel expense.

Net Loss: For the third quarter 2020, Selecta reported a net loss of $9.7 million, or $0.09 per share, compared to a net loss of $12.0 million, or $0.26 per share, for the same period in 2019.
Conference Call and Webcast Reminder:

Selecta management will host a conference call at 8:30 a.m. ET today to provide a corporate update and review the company’s third quarter 2020 financial results. Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10138608. Investors and the public can access the live and archived webcast of this call via the Investors & Media section of the company’s website, www.selectabio.com.

On November 5, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that on November 4, 2020 it entered into a privately negotiated exchange and purchase agreement (the "Agreement") with a holder of its currently outstanding 4.50% Convertible Senior Notes due 2024 (the "Existing 2024 Notes") (Press release, Clovis Oncology, NOV 5, 2020, View Source [SID1234570010]). Pursuant to the Agreement, in exchange for $64,842,000 aggregate principal amount of Existing 2024 Notes held by the holder (which is currently convertible into approximately 8.9 million shares of common stock), Clovis Oncology has agreed to issue to the holder a number of shares of the Company’s common stock (the "Exchanged Shares") utilizing an exchange ratio that is based in part on the daily volume-weighted average prices ("VWAPs") per share of Clovis Oncology’s common stock during a seven-trading day pricing period following execution of the Agreement.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, pursuant to the Agreement, Clovis Oncology has also agreed to sell to the holder $50,000,000 aggregate principal amount of a new series of 4.50% Convertible Senior Notes due 2024 (the "New 2024 Notes") at a purchase price of $1,000 per $1,000 principal amount thereof. Also, Clovis Oncology has granted the holder a 13-day option to purchase up to an additional $20,000,000 aggregate principal amount of New 2024 Notes on the same terms and conditions.

About the Debt Exchange

The number of Exchanged Shares to be issued by Clovis Oncology to the holder will be calculated utilizing an exchange ratio that is based in part on the average VWAPs of Clovis Oncology’s common stock (subject to a floor) during a seven-trading day pricing period beginning on November 5, 2020 and ending on, and including, November 13, 2020. Assuming such average VWAP is $5.67 per share, which is the last reported sale price of Clovis Oncology’s common stock on the Nasdaq Global Select Market on November 4, 2020, 13,038,683 Exchanged Shares would be issuable pursuant to the debt exchange transaction. However, in the event that Clovis Oncology’s stock price declines during the pricing period, Clovis Oncology will be required to issue more shares, but in no event more than 15,696,240 Exchanged Shares are issuable pursuant to the debt exchange transaction.

About the New 2024 Notes

The New 2024 Notes will bear interest at a rate of 4.50% per annum, payable semi-annually in arrears on February 1st and August 1st of each year. The New 2024 Notes will mature on August 1, 2024 unless earlier converted or repurchased. The holders of the New 2024 Notes may convert their notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date at an initial conversion rate of 160.3334 shares of Clovis Oncology’s common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of approximately $6.24 per share of common stock. The initial conversion price of the notes represents a premium of approximately 10% to the last reported sale price, $5.67 per share, of Clovis Oncology’s common stock on November 4, 2020.

Clovis Oncology will not have the right to redeem the New 2024 Notes prior to their maturity. Holders of the New 2024 Notes may require Clovis Oncology to repurchase for cash all or part of their notes upon certain fundamental changes at a repurchase price equal to 100% of the principal amount of the New 2024 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date, Clovis Oncology will, in certain circumstances, increase the conversion rate for a holder who elects to convert its New 2024 Notes in connection with such corporate event.

The above summary of the terms of the New 2024 Notes is qualified in its entirety by and should be read with the Indenture governing the New 2024 Notes, the form of which is anticipated to be filed with the Securities and Exchange Commission on or about November 5, 2020.

Clovis Oncology intends to use the net proceeds from the sale of the New 2024 Notes for general corporate purposes, including repayment, repurchase or refinance of its debt obligations, sales and marketing expenses associated with Rubraca (rucaparib), funding of its development programs, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

The issuance of the Exchanged Shares, the New 2024 Notes in the transaction and any shares of common stock issuable upon conversion of such New 2024 Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law, and, unless so registered, the New 2024 Notes and any such shares may not be offered or sold in the United States except pursuant to an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Clovis Oncology has agreed to file a registration statement for the resale of the shares of common stock issuable upon the conversion of the New 2024 Notes purchased by the holder. This press release does not constitute an offer to sell, or a solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering would be unlawful.

About the Settlement of the Transactions

The exchange and purchase transaction will settle in two parts. Approximately 8.9 million of the Exchanged Shares are expected to be issued on or about November 6, 2020 and the remainder will be issued within two business days following the seven-trading day pricing period and the final calculation of the exchange ratio, which is expected to occur on or about November 17, 2020. The sale of the New 2024 Notes is expected to occur on or about November 17, 2020. In each case, the settlement of the exchange and purchase transaction is subject to the satisfaction of customary closing conditions.

J.P. Morgan and BofA Securities acted as structuring banks to Clovis Oncology in connection with the transactions.

On November 5, 2020 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the third quarter ended September 30, 2020, and provided a business update (Press release, Radius, NOV 5, 2020, View Source [SID1234570009]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Over the past few months, we have made reasonable progress within the current business," commented Kelly Martin, CEO of Radius. Martin commented further that, "In the months ahead, we will focus on improving the performance of TYMLOS in the U.S. market, completing the three pivotal trials in a high quality manner, and constructing an attractive equity story for current or future shareholders."

Selected Highlights:

Q3 2020 U.S. net sales of TYMLOS were $50.4 million, an 8% year-over-year increase over Q3 2019.

Year-to-date 2020 net product revenue of $148 million vs. year-to-date of $117 million is a growth of 26%.

U.S. TYMLOS "Net New Patients" grew at 7+% in September vs. previous 3-month moving average.
º October Net New Patients showed 10 % growth vs. previous 3-month moving average.
º AACE guidelines include abaloparatide in the treatment recommendations as an initial therapy for postmenopausal osteoporosis patients with a recent fracture.
º Commercial business market segmentation and reengineering remains a central focus.
º Progress on implementation of a streamlined and institutional distribution channel strategy nearly complete.

Clinical Development
º ATOM study, evaluating abaloparatide for use in osteoporotic men at high risk for fracture, completed final recruitment of 228 patients.
º wearABLe study, evaluating the effects on bone mineral density of abaloparatide delivered via a novel transdermal system, completed final recruitment of 511 patients.
º EMERALD study, with our partner, Menarini Group, evaluating use of elacestrant to treat ER+/HER2- advanced or metastatic breast cancer completed final recruitment of 478 patients.
º Histomorphometry Phase 2 Study: data presented at American Society for Bone and Mineral Research (ASBMR) in September. Assessed early effect of abaloparatide at the tissue level. Results demonstrated significant increases in bone formation after three months in postmenopausal women with osteoporosis.
Japan: Pivotal Phase III trial of abaloparatide injection to treat both men and postmenopausal women with high risk of fracture by Radius partner, Teijin Pharma, achieved primary endpoint. Japan market progression remains on track.

Europe: seeking guidance and clarity regarding possible regulatory re-submission.
Financial Metric:

End of Q3 2020 total cash balance at $126 million
Q3 vs. Q2, 2020 cash burn approximately zero
Note: in Q3, Radius received a one-time payment from Menarini of $30M
Third Quarter 2020 Financial Results

Three Months Ended September 30, 2020

For the three months ended September 30, 2020, Radius reported a net loss of $6.3 million, or $0.14 per share, compared to a net loss of $30.0 million, or $0.65 per share, for the three months ended September 30, 2019.

For the three months ended September 30, 2020, non-GAAP adjusted net income, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $7.0 million, or $0.15 per share, compared to non-GAAP adjusted net loss of $20.4 million, or $0.44 per share, for the three months ended September 30, 2019.

For the three months ended September 30, 2020, TYMLOS net product revenues were $50.4 million compared to approximately $46.8 million for the three months ended September 30, 2019.

For the three months ended September 30, 2020, research and development expense was $39.5 million compared to $31.8 million for the three months ended September 30, 2019, an increase of $7.7 million, or 24%. This increase was primarily driven by a $11.5 million increase in abaloparatide transdermal system program costs. This increase was primarily offset by a $2.2 million decrease in elacestrant program costs, which is comprised of a $13.2 million increase in gross program expenses offset by $15.4 million of billed reimbursable expenses. We will be reimbursed for the costs incurred in connection with the elacestrant project pursuant to the terms of the TSA with Berlin-Chemie, under which the Company will perform certain services for Berlin-Chemie related to the EMERALD Phase 3 monotherapy study until the earlier of the completion of the contemplated services or the filing with the FDA of a NDA for elacestrant.

For the three months ended September 30, 2020, selling, general and administrative expenses were $33.7 million compared to $35.6 million for the three months ended September 30, 2019, a decrease of $1.9 million, or 5%. This decrease was primarily the result of a $0.8 million decrease in travel and entertainment expenses, a $2.3 million decrease in professional support costs, a $0.5 million decrease in compensation cost, and a $0.1 million decrease in other operating costs. These decreases were partially offset by a $1.8 million increase in occupancy and depreciation costs.

Nine Months Ended September 30, 2020

For the nine months ended September 30, 2020, Radius reported a net loss of $87.8 million, or $1.89 per share, compared to a net loss of $108.3 million, or $2.36 per share, for the nine months ended September 30, 2019.

For the nine months ended September 30, 2020, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $51.6 million, or $1.11 per share, compared to non-GAAP adjusted net loss of $77.6 million, or $1.69 per share, for the nine months ended September 30, 2019.

For the nine months ended September 30, 2020, TYMLOS net product revenues were $148.5 million compared to approximately $117.7 million for the nine months ended September 30, 2019.

For the nine months ended September 30, 2020, research and development expense was $123.3 million compared to $82.2 million for the nine months ended September 30, 2019, an increase of $41.1 million, or 50%. This increase was primarily driven by a $36.5 million increase in abaloparatide transdermal system project costs, and a $6.4 million increase in project costs for elacestrant. These increases were partially offset by a $1.0 million decrease in RAD140 project costs. We will be reimbursed for the costs incurred in connection with the elacestrant project pursuant to the terms of the TSA with Berlin-Chemie, under which the Company will perform certain services for Berlin-Chemie related to the EMERALD Phase 3 monotherapy study until the earlier of the completion of the contemplated services or the filing with the FDA of a NDA for elacestrant.

For the nine months ended September 30, 2020, selling, general and administrative expenses were $108.4 million compared to $116.9 million for the nine months ended September 30, 2019, a decrease of $8.6 million, or 7%. This decrease was primarily the result of a $6.3 million decrease in professional fees, a $3.3 million decrease in travel and entertainment expenses and a $0.3 million decrease in other operating expenses. These decreases were offset by a $0.3 million increase in compensation related expenses and an $1.0 million increase in occupancy and depreciation.

As of September 30, 2020, Radius had $126.3 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of September 30, 2020, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for at least twelve months from the date of this press release.

Webcast and Conference Call

In connection with today’s reporting of Third Quarter 2020 Financial Results, Radius will host a conference call and live audio webcast at 8:30 a.m. ET today, November 5, 2020, to review the commercial, research and development, and financial highlights and provide a Company update.

A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement and financial results will also be available on the Company’s website.

For those unable to participate in the conference call or webcast, a replay will be available on Thursday, November 5, 2020 at 11:30 a.m. ET and will be archived on the Company’s website for 90 days. To access the replay, dial (855) 859-2056 for U.S. or (404) 537-3406 for International, using conference ID number 9147422.