On October 29, 2020 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the third quarter ended September 30, 2020, and provided a business update on recent corporate and clinical developments (Press release, Protalix, OCT 29, 2020, View Source [SID1234569331]).

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"This quarter, we delivered on another important milestone for the Company with the FDA’s acceptance of, and grant of Priority Review designation to, the biologics license application (BLA) submitted for PRX-102 for the treatment of Fabry disease," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We continue to build-out our clinical data profile for PRX-102. The last patient has completed treatment in the BRIGHT study, and we expect to report top-line data from the study by the end of the first quarter, 2021. We remain focused on advancing our earlier stage pipeline as well. We are proud of our team’s continued dedication and collaboration in progressing on our corporate mission during these challenging times of the pandemic."

Recent Business Highlights

●Announced U.S. Food and Drug Administration (FDA) acceptance of the BLA submitted for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease and grant of Priority Review designation to the BLA. The BLA was submitted under the FDA’s accelerated approval pathway in collaboration with the Company’s development and commercialization partner, Chiesi Global Rare Diseases. The FDA indicated in its communications that it is not currently planning to hold an advisory committee meeting to discuss the application.
●The FDA set an action date of January 27, 2021 under the Prescription Drug User Fee Act (PDUFA) for the BLA. The FDA advised that, as part of its review of the BLA application, it requires an inspection of the Company’s manufacturing facility and that of a third party in Europe that performs fill and finish processes for PRX-102. Due to COVID-19 related FDA travel restrictions, the FDA has advised that it may be unable to conduct the inspections prior to the PDUFA date. Together with Chiesi, the Company is diligently exploring potential alternatives that would enable the FDA to meet its timeline. As part of such efforts, Chiesi submitted a request to the FDA for a Type A meeting. The

Company anticipates an FDA response to this request during the first week of November 2020.
● Disclosed the completion of the patient treatment period for the Company’s phase III BRIGHT clinical trial of PRX-102 for the treatment of Fabry disease. The trial was designed to evaluate the safety and efficacy of 2 mg/kg PRX-102 infused every four weeks, in Fabry patients. The Company expects to report top-line results from the trial by the end of the first quarter, 2021.
● Announced the launch of an Expanded Access Program in the United States for PRX-102 allowing a broader group of physicians and patients, beyond those in the Company’s phase III clinical program, access to PRX-102.
● Launched an at-the-market equity offering program with BofA Securities enabling the Company to sell up to $30 million shares of common stock according to the terms and conditions set forth in its agreement with BofA Securities. The program provides the Company with greater capital-raising flexibility as it executes on its commercialization and development plans.
Third Quarter 2020 Financial Highlights

The Company recorded revenues from selling goods of $3.3 million during the three months ended September 30, 2020, a decrease of $1.8 million, or 36%, compared to revenues of $5.1 million for the same period of 2019. The decrease resulted primarily from a timing difference in sales to Brazil in 2020 compared to 2019, which was partially offset by an increase in sales to Pfizer Inc.

Revenues from license and R&D services for the three months ended September 30, 2020 were $7.5 million, a decrease of $1.6 million, or 18%, compared to $9.1 million for the same period of 2019. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with its license and supply agreements with Chiesi. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX-102 as well as lower costs related to the Company’s phase III BALANCE clinical trial of PRX-102 for the treatment of Fabry disease.

Cost of goods sold for the three months ended September 30, 2020 was $2.9 million, a decrease of $0.3 million, or 11%, compared to $3.2 million for the same period of 2019. The decrease is primarily due to a change in the cost structure as well as lower royalties paid to the Israeli Innovation Authority.

Research and development expenses for the three months ended September 30, 2020 were $7.7 million, a decrease of $2.3 million, or 23%, compared to $10.0 million for the same period of 2019. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX-102 and reduced costs related to the BALANCE study as well as a decrease in costs

related to manufacturing of the Company’s drug in development as some of the manufactured drug product and related costs have been recorded as inventory.

Selling, general and administrative expenses for the three months ended September 30, 2020 were $2.8 million, an increase of $0.2 million, or 9%, compared to $2.6 million for the same period of 2019.

Financial expenses net for the three months ended September 30, 2020 were $1.9 million, a decrease of $0.1 million, or 8%, compared to $2.0 million for the same period of 2019.

Cash, cash equivalents and short-term bank deposits were approximately $41.3 million at September 30, 2020.

Conference Call and Webcast Information:

The Company will host a conference call on Thursday, October 29, 2020 at 8:30 am Eastern Daylight Time, to review the clinical, corporate, and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

The conference call will be webcast live from the Company’s website and will be available via the following links:

Company Link: View Source

Webcast Link: View Source

Conference ID: 13711708

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

On October 29, 2020 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported its operating and financial results for the third quarter ended September 30, 2020 (Press release, Genocea Biosciences, OCT 29, 2020, View Source [SID1234569329]).

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GEN-011 Phase 1/2a clinical trial initiation
Genocea recently announced the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) Application for GEN-011, an adoptive neoantigen T cell therapy designed to improve upon the limitations of TIL and TCR therapies. The company initiated a Phase 1/2a clinical study of GEN-011 in patients who have failed standard-of-care checkpoint inhibitor therapy to evaluate safety, T cell proliferation and persistence as well as clinical activity. Genocea plans to enroll up to 24 patients across several tumor types in the trial.

Scientific and clinical presentations: ESMO (Free ESMO Whitepaper) Congress, upcoming SITC (Free SITC Whitepaper) meeting and conference call
Genocea presented clinical response and immunogenicity data on the first five patients from Part B of the ongoing GEN-009 Phase 1/2a trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020. The incremental follow-up findings demonstrated tumor reductions or stable outcomes for all five patients, suggesting GEN-009 vaccination could be used in conjunction with CPI-based therapies to augment their effects. In addition, 100% of patients demonstrated immune responses to ATLAS-identified neoantigens.

Genocea will report additional clinical and immunogenicity data from the remaining GEN-009 Part B patients during the 2020 virtual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting from November 9-14. The company will also provide a detailed introduction to GEN-011 and will share new insights on the utility of ATLAS-identified Inhibigens to inform future immunotherapy development.

Genocea will host a conference call on Monday, November 9 at 8:30 a.m. EST to discuss the new GEN-009 clinical and immunogenicity data reported at SITC (Free SITC Whitepaper).

Private placement
In July, Genocea completed a private placement with $74.5 million in net proceeds. The proceeds will be used to fund continued development of GEN-009, GEN-011 and ATLAS.

"In the third quarter, our team achieved important clinical, scientific and financial progress. We provided what we believe to be differentiated immunogenicity and efficacy data from an initial look at our GEN-009 Part B clinical trial and secured critical fresh capital", said Chip Clark, president and chief executive officer Genocea. "Using these proceeds to advance GEN-011 into the clinic and to further our investigation into ATLAS and its applications represents an exciting opportunity."

Third Quarter 2020 Financial Results

Cash position: As of September 30, 2020, cash and cash equivalents were $87.6 million versus $40.1 million as of December 31, 2019.
Research and Development (R&D) expenses: R&D expenses were $7.5 million for the quarter ended September 30, 2020, compared to $6.8 million for the same period in 2019.
General and Administrative (G&A) expenses: G&A expenses were $3.6 million for the quarter ended September 30, 2020, compared to $2.8 million for the same period in 2019.
Net loss: Net loss was $4.6 million for the quarter ended September 30, 2020, compared to $7.5 million for the same period in 2019.
Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations to mid-2022.

Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. EDT. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 5951388. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On October 29, 2020 Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, reported financial results and business highlights for the third quarter of 2020 (Press release, Evelo Biosciences, OCT 29, 2020, View Source [SID1234569328]).

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"We can reduce systemic inflammation in humans by oral delivery of our candidate medicines which engage SINTAX, the small intestinal axis. We have accumulated the evidence for this from multiple cohorts of patients in two clinical trials. We are now building on these results in the next phases of development, with clinical trials across three distinct patient populations, including mid-stage studies in psoriasis and COVID-19," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "Together with our work on EDP1503 and EDP1867, we expect to announce six clinical results over the next three to nine months. In parallel, we have a remarkable discovery from our continued investment in research – microbial extracellular vesicles are a new form of SINTAX medicines that are now in preclinical development in both inflammation and oncology. Our portfolio is making significant progress towards our goal of providing therapies to patients with chronic inflammatory diseases and cancer."

Third Quarter 2020 Highlights and Recent Progress

Inflammation
EDP1815 in Psoriasis

Today, Evelo presented data from the Phase 1b clinical trial cohorts evaluating EDP1815 for the treatment of mild to moderate psoriasis at the European Academy of Dermatology and Venereology (EADV) Virtual Congress. The poster, as well as a prerecorded presentation, are now available online on the EADV conference website. The poster was selected as one of EADV’s key stories and highlighted at a virtual press conference at the event. Also at EADV, Evelo presented preclinical data, highlighting the potent anti-inflammatory effects of EDP1815 in murine models of TH1-, TH2- and TH17-mediated inflammation, including a model of chronic nervous system inflammation.
In October, Evelo dosed the first patients in the Phase 2 dose-ranging trial evaluating EDP1815 for the treatment of mild to moderate psoriasis. The trial is evaluating three doses of EDP1815 versus placebo in approximately 225 individuals, over a 16-week treatment period. The primary endpoint is mean reduction in PASI score.
EDP1815 in Atopic Dermatitis

In October, Evelo completed enrollment in the Phase 1b clinical trial cohort evaluating EDP1815 for the treatment of mild to moderate atopic dermatitis. The cohort is evaluating EDP1815 versus placebo in 24 individuals, over a 56-day treatment period. The primary endpoint is safety and tolerability.
EDP1815 in COVID-19

Patient recruitment continues in two studies evaluating EDP1815 for the treatment of newly hospitalized patients with COVID-19: the Phase 2 trial in partnership with Rutgers University, and TACTIC-E, a Phase 2/3 trial sponsored by the Cambridge University Hospitals NHS Foundation Trust and led by Addenbrooke’s Hospital in Cambridge, United Kingdom.
Evelo now expects to report data from the clinical trial in partnership with Rutgers University and interim safety data and futility analysis from TACTIC-E in 2Q 2021, depending on the prevalence of hospitalized patients with COVID-19. Subject to the receipt of positive data, Evelo plans to engage in discussions with global regulatory agencies to determine an appropriate path to registration for EDP1815 in COVID-19.
In order to expedite patient recruitment and expand access to potential therapies for COVID-19, new trial sites are being opened for TACTIC-E.
Business Highlights

In September 2020, Evelo appointed Julie Carretero as Chief People Officer. In her role, Ms. Carretero is responsible for leading the Company’s people initiatives, including talent acquisition and employee development.
In October 2020, the U.S. Patent and Trademark Office issued to Evelo U.S. Patent No. 10,792,314, entitled "Compositions and methods of treating cancer using Bifidobacterium animalis ssp. lactis." The patent covers a pharmaceutical composition formulated for oral administration comprising Bifidobacterium animalis ssp. Lactis Strain A and a pharmaceutically acceptable carrier within an enteric coating.
Upcoming Key Milestones
EDP1815

Data from Phase 1b trial in mild to moderate atopic dermatitis in 1Q 2021
Data from Phase 2 Rutgers University trial in COVID-19 in 2Q 2021
Interim safety data and futility analysis from Phase 2/3 TACTIC-E trial in COVID-19 in 2Q 2021
Interim data from Phase 2 trial in mild to moderate psoriasis by mid-2021
EDP1867

Data from Phase 1b trial in atopic dermatitis in mid-2021
EDP1503

Additional data from Phase 1/2 trial in triple-negative breast cancer (TNBC) accepted for poster presentation at the 2020 San Antonio Breast Cancer Symposium (SABSC), to be held virtually from December 8-11
EDP1908

Abstract titled "Oral delivery of a microbial extracellular vesicle induces potent anti-tumor immunity in mice," accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, to be held virtually from November 11-14
Third Quarter 2020 Financial Results

Cash Position: As of September 30, 2020, cash and cash equivalents were $81.6 million, as compared to cash and cash equivalents of $77.8 million as of December 31, 2019. This increase was primarily due to $48.4 million in net proceeds from the Company’s June 2020 follow-on offering and draw down of an additional $10 million under its existing debt facility in July 2020, partially offset by cash used in operating activities. Evelo expects that its cash and cash equivalents will enable it to fund its planned operating expenses and capital expenditure requirements into the beginning of the third quarter of 2021.
Research and Development Expenses: R&D expenses were $14.9 million for the three months ended September 30, 2020, compared to $15.6 million for the three months ended September 30, 2019. The decrease of $0.7 million was primarily due to decrease in platform expenses and oncology program spend primarily driven by COVID-19 pandemic impact, partially offset by increases in inflammation programs and personnel costs due to advancing EDP1815 into Phase 2, additional trials and headcount increase in R&D.
General and Administrative Expenses: G&A expenses were $5.3 million for the three months ended September 30, 2020, compared to $5.9 million for the three months ended September 30, 2019. The decrease of $0.6 million was primarily due to lower personnel costs associated with temporarily lower general and administrative headcount and lower professional fees, partially offset by higher facility and office costs due to the impact of the COVID-19 pandemic.
Net Loss: Net loss was $20.9 million for the three months ended September 30, 2020, or $(0.45) per basic and diluted share, as compared to a net loss of $21.6 million for the three months ended September 30, 2019, or $(0.67) per basic and diluted share.
Conference Call
Evelo will host a conference call and webcast at 8:30 a.m. ET today to review third quarter 2020 highlights. To access the call, please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 5480508. A live webcast of the event will also be available under "News and Events" in the Investors section of Evelo’s website at View Source The archived webcast will be available on Evelo’s website approximately two hours after the completion of the event and will be available for 30 days following the call.

On October 29, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended September 30, 2020 and provided an update of key milestones (Press release, Lexicon Pharmaceuticals, OCT 29, 2020, View Source [SID1234569327]).

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"In the third quarter, we streamlined our operations to prioritize our focus on our advancement of LX9211, a promising drug candidate with potential to become a treatment option for the millions of people living with neuropathic pain. Most people suffering with neuropathic pain experience only limited success with available therapies while enduring substantial side effects," said Lonnel Coats, Lexicon’s president and chief executive officer. "We have commenced our first Phase 2 study in diabetic peripheral neuropathic pain and plan to commence our second Phase 2 study in post-herpetic neuralgia shortly with results for both studies expected by the end of next year."

Third Quarter Highlights

LX9211

Commenced patient dosing in RELIEF-DPN-1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain. Enrollment is expected to total approximately 300 patients at 30 U.S. clinical sites.
Preparing to commence an additional Phase 2 study of LX9211 in post-herpetic neuralgia later this year.
Realignment and Debt Reduction

Realignment of the business around LX9211, sotagliflozin and other drug discovery and development programs.
Reduced outstanding debt by more than 90%, including the elimination of its $150 million secured term loan and $75.8 million principal amount of its 5.25% Convertible Senior Notes due 2021.
XERMELO (telotristat ethyl)

XERMELO U.S. net sales were $6.5 million in the third quarter of 2020, reflecting sales during the quarter prior to the completion of the sale of XERMELO and related assets to TerSera Therapeutics LLC on September 8, 2020.
Received $160.4 million in cash at closing of the sale and eligible to receive up to $65 million in additional milestone payments for the development and commercialization of XERMELO in patients with biliary tract cancer and mid-teens royalties on net sales of XERMELO in biliary tract cancer.
Sotagliflozin

Announced topline data from four Phase 3 sotagliflozin studies in type 2 diabetes: SOTA-MONO, SOTA-SU, SOTA-GLIM and SOTA-INS with all four studies meeting their primary objectives of lowering A1C in patients with type 2 diabetes.
Upcoming Milestones

Q4 2020: Initiation of a Phase 2 study for LX9211 in post-herpetic neuralgia.
Q4 2020: Presentation of data from the sotagliflozin SOLOIST and SCORED Phase 3 studies at the American Heart Association Scientific Sessions 2020.
Q4 2021: Phase 2 study results in diabetic peripheral neuropathic pain and in post-herpetic neuralgia.
Third Quarter 2020 Financial Highlights

Revenues: Revenues for the three months ended September 30, 2020 decreased to $6.6 million from $294.4 million for the corresponding period in 2019. The three months ended September 30, 2019 included collaborative revenues of $260.0 million from the termination of the alliance with Sanofi and recognition of the remaining amount of $23.5 million allocated to performance obligations from the initial agreement with Sanofi. Net product revenues for the three months ended September 30, 2020 consisted of $6.5 million from net sales of XERMELO in the U.S.

Cost of Sales: Cost of sales related to sales of XERMELO for the three months ended September 30, 2020 and 2019 were $0.6 million.

Research and Development (R&D) Expenses: Research and development expenses for the three months ended September 30, 2020 increased to $40.1 million from $26.7 million for the corresponding period in 2019, primarily due to increases in external clinical development costs related to sotagliflozin subsequent to the termination of the alliance with Sanofi.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended September 30, 2020 decreased to $12.0 million from $13.9 million for the corresponding period in 2019.

Gain on Sale of XERMELO: A gain of $132.8 million was recognized for the three months ended September 30, 2020 from the sale of XERMELO and related assets to TerSera.

Net Income: Net income for the three months ended September 30, 2020 was $82.6 million, or $0.71 per diluted share, as compared to net income of $226.1 million, or $1.95 per diluted share, in the corresponding period in 2019. For the three months ended September 30, 2020 and 2019, net loss included non-cash, stock-based compensation expense of $1.9 million and $3.6 million, respectively.

Cash and Investments: As of September 30, 2020, Lexicon had $111.4 million in cash and investments, as compared to $271.7 million as of December 31, 2019.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is (888) 645-5785 (U.S./Canada) or (970) 300-1531 (international). The conference ID for all callers is 7787988. The live webcast and replay may be accessed by visiting Lexicon’s website at View Source An archived version of the webcast will be available on the website for 14 days.

About LX9211

LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target with a pain phenotype discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.

About Sotagliflozin

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched.

On October 29, 2020 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that the Company’s third quarter 2020 financial results will be released on Thursday, November 5, 2020 (Press release, Calithera Biosciences, OCT 29, 2020, View Source [SID1234569326]). Company management will host a conference call on Thursday, November 5, 2020 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 6869011. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.