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Prothena Reports Third Quarter 2020 Financial Results and Provides R&D Update

On November 4, 2020 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of investigational therapeutics for neurodegenerative and rare peripheral amyloid diseases, reported financial results for the third quarter and first nine months of 2020 (Press release, Prothena, NOV 4, 2020, View Source [SID1234569993]). In addition, the Company provided an update on its R&D programs.

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"During the third quarter, Roche presented data from the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson’s disease that demonstrated signals of efficacy consistent with disease modification and recently, we announced that prasinezumab will advance into a late-stage study," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "Moving into the fourth quarter, we are building on this momentum with two new data presentations from our Alzheimer’s disease portfolio at CTAD 2020 this week and additional data from our Phase 1 study of PRX004 in ATTR amyloidosis is expected later this quarter. Looking ahead, we remain focused on advancing our R&D pipeline towards key milestones."

Third Quarter and Recent Highlights

Announced results from the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson’s disease that were presented by Roche at the International Parkinson and Movement Disorder Society’s MDS Virtual Congress 2020 (MDS Congress 2020) on September 15, 2020. Prasinezumab is the first potentially disease-modifying, anti-alpha-synuclein antibody to demonstrate signs of efficacy on multiple pre-specified secondary and exploratory clinical endpoints in patients with early Parkinson’s disease. In the study, prasinezumab significantly reduced decline in motor function by 35% (pooled dose levels) vs. placebo after one year of treatment on the centrally rated assessment of Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III, a clinical examination of motor function. Prasinezumab-treated patients also demonstrated a significant delay in time to clinically meaningful worsening of motor progression on the site rated assessment of time to at least a 5-point progression on MDS-UPDRS Part III vs. placebo over one year, with a hazard ratio of 0.82 (pooled dose levels).
Announced that Roche and Prothena will advance prasinezumab into a late-stage (Phase 2b) study in patients with early Parkinson’s disease. The study will be designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA to include patients with early Parkinson’s disease on stable levodopa therapy.
Presented preclinical data from two programs in its Alzheimer’s disease portfolio at the 13th Clinical Trials on Alzheimer’s Disease Conference 2020 (CTAD 2020). First, a next generation anti- Aβ antibody, PRX012, for more convenient subcutaneous administration to improve patient access. Second, a multi-immunogen vaccine that targets both Aβ and Tau, two main pathological hallmarks of Alzheimer’s disease, for the prevention and treatment of Alzheimer’s disease.
Upcoming Research and Development Milestones

Prasinezumab (PRX002/RG7935), a potential treatment for Parkinson’s disease, is a monoclonal antibody designed to target alpha-synuclein and is the focus of the worldwide collaboration with Roche

Part 2 of the Phase 2 PASADENA study (a 52-week blinded extension phase) is ongoing.
Prothena will earn a $60 million clinical milestone payment upon the first patient dosed in the Phase 2b study. Further details are expected to be announced in the first half of 2021.
PRX004, a potential treatment for ATTR amyloidosis, is a monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein

Prothena expects to report new data in fourth quarter of this year from the dose-escalation and available LTE portion of the study.
Prothena continues to believe that the study has advanced sufficiently to determine next steps for the program and has begun further clinical development planning for next clinical studies in patients with moderate-to-advanced ATTR cardiomyopathy (ATTR-CM). Current therapies have not demonstrated efficacy in these patients who are at high risk of early mortality.
Discovery and Preclinical Development: Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications

Prothena continues to expect to advance IND-enabling activities in 2020 for PRX005, our preclinical tau program, part of a global neuroscience collaboration with Bristol-Myers Squibb, and expects to file an IND in 2021.
Prothena has initiated IND-enabling studies for PRX012, our preclinical Aβ program, and expects to file an IND in 2021.
Upcoming Investor Conferences

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

Stifel 2020 Virtual Healthcare Conference on Tuesday November 17, 2020 at 4:00 PM Eastern Time
Jefferies Virtual London Healthcare Conference on Thursday November 19, 2020 at 2:55 PM Eastern Time
A live webcast of the presentations can be accessed through the Investors section of the Company’s website at www.prothena.com. Following the live presentations, a replay of the webcast will be available on the Company’s website for at least 90 days following the presentation date.

Third Quarter and First Nine Months of 2020 Financial Results

For the third quarter and first nine months of 2020, Prothena reported a net loss of $30.6 million and $80.4 million, respectively, as compared to a net loss of $19.4 million and $56.1 million for the third quarter and first nine months of 2019, respectively. The third quarter and first nine months of 2019 included a restructuring credit of nil and $0.1 million, respectively, which resulted from an adjustment in previously recorded employee termination benefits associated with the discontinuation of the NEOD001 program. Net loss per share for the third quarter and first nine months of 2020 was $0.77 and $2.02, respectively, as compared to a net loss per share of $0.49 and $1.41 for the third quarter and first nine months of 2019, respectively.

Prothena reported total revenue, primarily from its collaboration with Roche, of $0.2 million and $0.5 million for the third quarter and first nine months of 2020, respectively as compared to total revenue of $0.2 million and $0.6 million for the third quarter and first nine months of 2019, respectively.

Research and development (R&D) expenses totaled $21.6 million and $54.1 million for the third quarter and first nine months of 2020, respectively, as compared to $12.5 million and $35.4 million for the third quarter and first nine months of 2019, respectively. The increase in R&D expense for the third quarter and first nine months of 2020 compared to the same periods in the prior year was primarily due to higher manufacturing costs, higher collaboration expense with Roche related to the prasinezumab program and higher R&D consulting expense. R&D expenses included non-cash share-based compensation expense of $2.1 million and $6.2 million for the third quarter and first nine months of 2020, respectively, as compared to $2.0 million and $6.2 million for the third quarter and first nine months of 2019, respectively.

General and administrative (G&A) expenses totaled $9.4 million and $28.8 million for the third quarter and first nine months of 2020, respectively, as compared to $8.7 million and $27.7 million for the third quarter and first nine months of 2019, respectively. The increase in G&A expenses for the third quarter and first nine months of 2020 compared to the same periods in the prior year was primarily related to higher costs for our director and officer insurance premiums offset in part by lower share-based compensation expense. G&A expenses included non-cash share-based compensation expense of $3.5 million and $10.6 million for the third quarter and first nine months of 2020, respectively, as compared to $3.9 million and $12.1 million for the third quarter and first nine months of 2019, respectively.

Total non-cash share-based compensation expense was $5.6 million and $16.8 million for the third quarter and first nine months of 2020, respectively, as compared to $5.8 million and $18.3 million for the third quarter and first nine months of 2019, respectively.

As of September 30, 2020, Prothena had $317.2 million in cash, cash equivalents and restricted cash and no debt.

As of October 30, 2020, Prothena had approximately 39.9 million ordinary shares outstanding.

The Company continues to expect its full year 2020 net cash burn from operating and investing activities to be $75-$85 million and expects to end the year with approximately $299 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2020 net cash burn from operating and investing activities is primarily driven by estimated net loss of $101-$118 million, which includes an estimated $23 million of non-cash share-based compensation expense.

Inducement Grant Under NASDAQ Listing Rule 5635(C)(4)

In connection with hiring two new employees, the compensation committee of the Company’s board of directors granted the individuals hired by the Company, in the aggregate, options to purchase 90,000 ordinary shares of the Company. The options have an exercise price per share equal to $11.03, which was the closing trading price on November 2, 2020, the date of the grants. The inducement awards will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the date of grants and 1/48th of the underlying shares vesting monthly thereafter over 36 months. The options were granted pursuant to the Company’s 2020 Employment Inducement Incentive Plan, which was approved by the Company’s board of directors under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company.

Sangamo Therapeutics Reports Business Highlights and Third Quarter 2020 Financial Results

On November 4, 2020 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported third quarter 2020 financial results and recent business highlights (Press release, Sangamo Therapeutics, NOV 4, 2020, View Source [SID1234569992]).

"We are pleased with the clinical execution momentum across our portfolio, including the first patient dosed in the registrational AFFINE study of our investigational hemophilia A gene therapy partnered with Pfizer, as well as dosing of the first two patients in the Phase 1/2 STAAR study evaluating our Fabry disease gene therapy," said Sandy Macrae, CEO of Sangamo. "We also continue to advance our research projects, exemplified by the completion of our research activities in our ALS program partnered with Pfizer."

Business Updates

Earned a $30 million milestone from Pfizer for the dosing of the first patient in the registrational Phase 3 AFFINE study of investigational hemophilia A gene therapy giroctocogene fitelparvovec (SB-525).
Pfizer provided updated data from the Phase 1/2 Alta study of giroctocogene fitelparvovec demonstrating tolerability, clinically meaningful factor levels with no bleeds and no prophylactic factor use through up to 85 weeks in the longest patient treated in the highest dose cohort.
Completed dosing of the first two patients in our Phase 1/2 STAAR study evaluating our investigational ST-920 gene therapy in Fabry disease.
Received additional regulatory approvals supporting the first-in-human Phase 1/2 STEADFAST study evaluating our CAR-Treg product candidate TX200 in kidney transplantation.
Completed our research activities in our collaboration with Pfizer to develop gene regulation therapies using zinc finger protein transcription factors for the treatment of C9ORF72-related Amyotrophic Lateral Sclerosis (ALS). Earned a $5 million milestone related to the program.
Appointed Dr. Kenneth Hillan MB ChB, to our Board of Directors.
Third Quarter 2020 Financial Results

Cash, cash equivalents and marketable securities were $694.6 million as of September 30, 2020, compared to $384.3 million as of December 31, 2019. The balance at the end of the third quarter includes the previously announced $75.0 million upfront license fee from Novartis. We expect to receive the $35 million in milestone payments from Pfizer in the fourth quarter.

Consolidated net loss attributable to Sangamo for the third quarter ended September 30, 2020 was $1.6 million, or $0.01 per share, compared to a net loss of $27.3 million, or $0.24 per share, for the same period in 2019. Revenues for the third quarter ended September 30, 2020 were $57.8 million, compared to $22.0 million for the same period in 2019.

Total operating expenses were $61.5 million for the third quarter ended September 30, 2020, compared to $51.2 million for the same period in 2019. Non-GAAP operating expenses, which exclude stock-based compensation expense, were $54.8 million for the third quarter ended September 30, 2020, compared to $46.5 million for the same period in 2019. The increase in operating expenses reflects our headcount growth and facilities expansion to support the advancement of our therapeutic pipeline and manufacturing capabilities. These increases were partially offset by a decrease in clinical and manufacturing supply expenses.

Revised Financial Guidance for 2020

We are revising our full year operating expense guidance initially provided on February 28, 2020 and revised on August 5, 2020 as follows:

Conference Call

Sangamo will host a conference call today, November 4, 2020, at 5:00 p.m. Eastern Time, which will be open to the public. The call will also be webcast with live Q&A and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 2575067. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 2575067.

G1 Therapeutics Provides Third Quarter 2020 Corporate and Financial Update

On November 4, 2020 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the third quarter ended September 30, 2020 (Press release, G1 Therapeutics, NOV 4, 2020, View Source [SID1234569991]).

"Since I joined G1 in 2014, the company has made tremendous progress in advancing trilaciclib from the lab to receiving Priority Review for our NDA and a PDUFA action date of February 15, 2021. We have built exceptional commercial and medical teams that are prepared for the potential approval of trilaciclib in the first quarter of next year. In addition, we have developed a comprehensive clinical and regulatory strategy to evaluate the use of trilaciclib in other solid tumors, including a registrational trial in metastatic colorectal cancer that is on track to start this quarter," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "It has been a privilege to work with the talented team at G1 to accomplish these goals, and I am equally fortunate to be handing the reins to Jack Bailey, our board member and incoming CEO. Jack is a superb leader with extensive experience launching novel therapeutics and managing product development to maximize benefit to patients."

Regulatory, Clinical and Corporate Highlights

NDA for trilaciclib in small cell lung cancer (SCLC) accepted by FDA and assigned Priority Review in August 2020. The application was supported by positive data from three randomized clinical trials showing the myelopreservation benefits of trilaciclib in patients with SCLC being treated with chemotherapy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2021 (press release here). Trilaciclib has also received Breakthrough Therapy Designation by the FDA.
Additional analyses of trilaciclib SCLC trial results presented at North America Conference on Lung Cancer (NACLC). A mini-oral session highlighted analysis of three randomized trials in patients with small cell lung cancer that showed trilaciclib significantly reduced hospitalizations caused by chemotherapy-induced myelosuppression or sepsis.
Completed enrollment in rintodestrant/palbociclib combination trial in October 2020. The company expects preliminary safety, tolerability and efficacy data from 40 patients enrolled in this Phase 2 trial to be presented in the second quarter of 2021. The trial is comparing a treatment regimen of rintodestrant plus palbociclib (known commercially as Ibrance) to fulvestrant plus palbociclib in patients with ER+, HER2- breast cancer.
CEO succession plan announced in September 2020. Effective January 1, 2021, Mark Velleca, M.D., Ph.D., will transition to the role of senior advisor and continue to serve as a member of the G1 Board of Directors. John ("Jack") Bailey, a member of the company’s board, has been named as CEO (press release here).
"I’m excited to have the opportunity to lead G1 through its next chapter as a commercial company," said Jack Bailey, incoming CEO. "Our top priorities remain the successful execution of our launch strategy for trilaciclib in small cell lung cancer and advancing the clinical development of trilaciclib in other tumor types. I’ve gotten to know the team at G1 since joining the board earlier this year, and have been struck by their desire to help patients. It’s a privilege to join this group that shares a common passion for delivering better treatment options to people living with cancer."

Third Quarter 2020 Financial Highlights and 2020 Guidance

Cash Position: Cash and cash equivalents totaled $238.3 million as of September 30, 2020, compared to $269.2 million as of December 31, 2019.
License Revenue: License revenues were $26.6 million for the third quarter of 2020, mostly related to the upfront cash payments from license agreements of $20.0 million and $6.0 million from EQRx, Inc. and Genor Biopharma, Inc., respectively.
Operating Expenses: Operating expenses were $36.3 million for the third quarter of 2020, compared to $34.0 million for the third quarter of 2019. GAAP operating expenses include stock-based compensation expense of $4.9 million for the third quarter of 2020, compared to $4.4 million for the third quarter of 2019.
Research and Development Expenses: Research and development (R&D) expenses for the third quarter of 2020 were $17.9 million, compared to $22.9 million for the third quarter of 2019. The decrease in R&D expenses was primarily due to a decrease of $4.6 million in costs for manufacturing active pharmaceutical ingredients, as well as a decrease of $1.6 million in external costs related to discovery and pre-clinical costs development. The decrease is partially offset by an increase of $1.2 million in spend for clinical trials.
General and Administrative Expenses: General and administrative (G&A) expenses for the third quarter of 2020 were $18.4 million, compared to $11.1 million for the third quarter of 2019. The increase in G&A expenses was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, and an increase in professional fees and other administrative costs necessary to support our commercial operations.
Net Loss: G1 reported a net loss of $11.7 million for the third quarter of 2020, compared to $32.4 million for the third quarter of 2019.
2020 Guidance: The company has updated its cash and cash equivalents guidance provided in the second quarter, and now expects to end 2020 with cash and cash equivalents of $200-$205 million (previous guidance of $185-$200 million). This guidance does not include consideration of potential additional proceeds from partnerships, collaboration activities and/or other sources of capital.
Key Anticipated 2020/2021 Milestones

Initiation of Phase 3 trilaciclib metastatic colorectal cancer clinical trial in November/December 2020.
Presentation of additional Phase 2 data of trilaciclib in triple-negative breast cancer at the San Antonio Breast Cancer Summit (SABCS) in December 2020.
Presentation of additional rintodestrant monotherapy data at SABCS in December 2020.
Pending FDA approval, commercial launch of trilaciclib in SCLC in 1Q21.
Presentation of rintodestrant/palbociclib Phase 2 data in 2Q21.
Webcast and Conference Call
The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the third quarter 2020 ended September 30, 2020. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 6634419. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

AnaptysBio Announces Third Quarter 2020 Financial Results and Provides Pipeline Updates

On November 4, 2020 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the third quarter ended September 30, 2020 and provided pipeline updates (Press release, AnaptysBio, NOV 4, 2020, View Source [SID1234569972]).

"We are excited with the recent interim results from our GALLOP trial and look forward to engaging with regulatory authorities to progress imsidolimab into registration trials for the treatment of GPP," said Hamza Suria, president and chief executive officer of AnaptysBio. "Under our amended immuno-oncology collaboration with GSK, we look forward to the anticipated first FDA approval of dostarlimab and its advancement for patients suffering with various oncological disorders."

Imsidolimab (Anti-IL-36 Receptor) Program

In July, we announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, our proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with GPP. Treatment of GPP by imsidolimab is being evaluated in the GALLOP Phase 2 trial.

Patients demonstrated rapid onset, overall safety and promising efficacy upon imsidolimab monotherapy in a Day 29 interim analysis of our GALLOP Phase 2 GPP trial. Six of 8 patients achieved the primary endpoint of disease improvement upon Day 29, while erythema with skin pustules, which clinically defines GPP, decreased by 94% on Day 29 relative to baseline.
An end-of-Phase 2 meeting, based upon data available from the 8 patients enrolled in the GALLOP trial, is anticipated in Q4 2020.

We are also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in approximately 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, which is now fully enrolled with topline data anticipated in Q1 2021.

We anticipate expanding the imsidolimab program in two new indications, EGFR-mediated skin toxicities and ichthyosis, based upon human translational data that suggests each of these conditions are mediated by dysregulated signaling through the IL-36 pathway. Initiation of Phase 2 trials for each of these indications is anticipated in Q4 2020.

Worldwide registry of GPP and PPP patients, named RADIANCE, to be initiated in Q1 2021, to improve understanding of the patient journey and support enrollment of future trials.
ANB030 (Anti-PD-1 Agonist) Program

We anticipate topline data from our ongoing Phase 1 healthy volunteer clinical trial of ANB030, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of ANB030 in single and multiple ascending dose cohorts in mid-2021. Preclinical translational data using ANB030 was presented in March 2020 at the Festival of Biologics Meeting.
ANB032 (Anti-BTLA Modulator) Program

We anticipate filing an investigational new drug application (IND) for ANB032, our wholly-owned BTLA modulator antibody, in Q4 2020. We presented preclinical data regarding ANB032 at the 2020 Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting in October 2020.
Etokimab (ANB020 Anti-IL-33) Program

In an interim analysis at week 8 of the ongoing ECLIPSE Phase 2 trial of etokimab in chronic rhinosinusitis with nasal polyps, patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant improvement in their bilateral nasal polyps score (NPS), an endoscopic measure of nasal occlusion, and their sino-nasal outcome test (SNOT-22), a patient reported quality-of-life assessment, versus placebo at the week 8 timepoint. Both endpoints demonstrated statistically significant improvement over baseline levels of NPS and SNOT-22. Blood eosinophil levels, which are a biomarker of etokimab’s mechanism, demonstrated statistically significant reduction relative to baseline in both etokimab treatment arms. We intend to decide on a path forward for the etokimab program after reviewing week 16 primary endpoint data by year-end 2020.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK

In October 2020, we amended our immuno-oncology collaboration with GSK resulting in increased financial consideration to AnaptysBio. Royalties due to AnaptysBio for dostarlimab were increased to 8-25% of global net sales, where AnaptysBio will receive 8% of annual global net sales below $1 billion, and 12-25% of net sales above $1 billion. The $1.1 billion in cash milestone payments due under the collaboration agreement remain unchanged, and AnaptysBio anticipates receiving $75 million in such cash milestones over the next 18 months as dostarlimab obtains FDA and EMA regulatory approval for the first two indications. An additional $165 million in sales milestones is anticipated by AnaptysBio upon achievement of certain dostarlimab annual sales revenues. GSK has also agreed, starting January 1, 2021, to pay AnaptysBio a 1% royalty on all of GSK’s global net sales of Zejula. In addition, GSK has agreed to pay AnaptysBio a one-time cash payment of $60 million within 30 days. In exchange, AnaptysBio has provided GSK with freedom to conduct development and commercialization of Zejula in combination with third-party molecules and settled the ongoing legal dispute between AnaptysBio and GSK.
Third Quarter Financial Results

Cash, cash equivalents and investments totaled $374.5 million as of September 30, 2020 compared to $428.5 million as of December 31, 2019, for a decrease of $54.0 million. The decrease relates primarily to cash used for operating activities.

Collaboration revenue was zero and $15.0 million for the three and nine months ended September,30 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab by GSK, compared to zero and $5 million for the three and nine months ended September 30, 2019.

Research and development expenses were $19.5 million and $58.5 million for the three and nine months ended September 30, 2020, compared to $29.9 million and $77.9 million for the three and nine months ended September 30, 2019. The decrease was due primarily to reduced outside services for manufacturing and clinical expenses based on the timing of projects.

General and administrative expenses were $4.8 million and $13.8 million for the three and nine months ended September 30, 2020, compared to $3.8 million and $12.3 million for the three and nine months ended September 30, 2019. The increase was due primarily to increased legal and insurance expenses.

Net loss was $23.8 million and $53.6 million for the three and nine months ended September 30, 2020, or a net loss per share of $0.87 and $1.96, compared to a net loss of $31.0 million and $77.1 million for the three and nine months ended September 30, 2019, or a net loss per share of $1.15 and $2.85.

Financial Guidance
AnaptysBio expects its net cash burn in 2020 will be close to breakeven assuming the $20 million milestone payment upon first FDA approval of dostarlimab is received by year-end. We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2023.

SHINE announces first sales of n.c.a. Lu-177

On November 4, 2020 SHINE Medical Technologies reported that its Therapeutics division has made its first commercial sales of lutetium-177 to multiple customers (Press release, Shine Medical Technologies, NOV 4, 2020, View Source;pk_kwd=shine-announces-first-sales-of-n-c-a-lu-177 [SID1234569969]). Lutetium-177, or Lu-177, is a therapeutic isotope in demand by clinical trial sponsors because of its potential to revolutionize the treatment of cancer patients. There are dozens of clinical trials studying Lu-177’s potential to treat a range of cancers.

"SHINE’s recent sales of Lu-177 are a significant milestone for the company and important validation of our production and commercial processes," said Katrina Pitas, vice president and general manager of SHINE Therapeutics. "We look forward to serving customers in both the clinical trial and cancer therapy markets. We expect demand for Lu-177 to grow rapidly as its efficacy and impact on the field of cancer therapy continue to be demonstrated."

SHINE’s Lu-177 production process enables the company to produce the high specific activity, non-carrier-added Lu-177 that is required by today’s clinical trials. SHINE’s technology also has unique advantages that allow the company to scale production of the isotope quickly and more efficiently. The technology was developed with the help of SHINE’s scientific partners in the Czech Republic, the Institute of Organic Chemistry and Biochemistry (IOCB Prague) and the Nuclear Physics Institute (NPI) of the Czech Academy of Sciences.

Building One, the first building on SHINE’s isotope production campus, will serve as the company’s bridge production facility. SHINE will produce Lu-177 under GMP conditions at Building One in the short term, while the company builds a larger facility exclusively for the production of Lu-177. Groundbreaking for the larger facility is expected in November. SHINE’s new therapeutic isotope production facility will be able to scale to support the company’s anticipated Lu-177 demand for the next five years. It will be capable of producing more than 300,000 doses of Lu-177 per year.

"This milestone is really exciting, as Lu-177 is effectively a smart bomb for certain types of cancer," said Greg Piefer, CEO of SHINE. "The ability to target metastatic cancer with very high precision can give hope of survival to patients who previously have had no real options. We’re enthusiastic about bringing our core competencies to this market, and believe we’ll play a major role in ensuring patients worldwide will have access to this very important isotope."

Lu-177 is a low-energy beta-particle emitter that works by directly irradiating cancer cells after being delivered to the cancer site by a targeting molecule. Lu-177 is used to treat neuroendocrine cancers. It also shows promise for the treatment of metastatic prostate and other cancers.