On March 12, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months and full-year ended December 31, 2019 and provided a business update (Press release, Lexicon Pharmaceuticals, MAR 12, 2020, View Source;2020.htm [SID1234555457]).

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"In 2019, we achieved continued growth in our XERMELO (telotristat ethyl) business of nearly 25% year-over-year and made significant strides in advancing pipeline initiatives such as telotristat ethyl in biliary tract cancer and LX9211 in neuropathic pain," said Lonnel Coats, Lexicon’s president and chief executive officer. "We expect initial clinical efficacy data for telotristat ethyl in biliary tract cancer by the end of this year. As for LX9211, we are initiating a proof-of-concept study in diabetic peripheral neuropathic pain in the first half of this year."

"We received a response yesterday from the Center for Drug Evaluation and Research (CDER) to our appeal of the FDA’s complete response letter (CRL) for sotagliflozin in type 1 diabetes," continued Mr. Coats. "The response confirmed the CRL decision, and we are now evaluating the feedback they provided in their response."

"We are engaged in discussions around potential partnerships for sotagliflozin, which will be necessary to enable completion of the long-term outcomes studies, SCORED and SOLOIST, that are designed to demonstrate benefits in and support labeling for heart failure and chronic kidney disease."

Fourth Quarter and Full-Year 2019 Product and Pipeline Highlights

XERMELO (telotristat ethyl)

•XERMELO U.S. net sales were $31.0 million in 2019.
•In December, Lexicon completed a safety review of the initial safety run-in cohort of The Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, a Phase 2a clinical study of telotristat ethyl in patients with biliary tract cancer. Safety analysis from the first six patients who completed at least a 21-day cycle of treatment with telotristat ethyl in combination with cisplatin and gemcitabine supported the continuation of enrollment with no adjustment in the telotristat ethyl 500 mg three times daily dosing regimen.

Zynquista (sotagliflozin)

•In December, Lexicon announced topline data from the Phase 3 SOTA-EMPA study of sotagliflozin in type 2 diabetes. Sotagliflozin 400 mg achieved the primary endpoint of superiority on A1C reduction versus placebo at Week 26 in patients with inadequate glycemic control while on a dipeptidyl peptidase 4 inhibitor, with or without metformin therapy. Sotagliflozin 400mg also achieved the key secondary endpoint of noninferiority versus empagliflozin on A1C reduction from baseline at Week 26. Sotagliflozin was generally well tolerated, with safety results comparable to previously reported safety results in patients with type 2 diabetes.

•In December, Lexicon announced that the U.S. Food and Drug Administration’s (FDA) Office of New Drugs had reiterated the FDA’s prior position that the New Drug Application for sotagliflozin in type 1 diabetes cannot be approved in its present form and denied the appeal of the previously issued CRL. Lexicon subsequently appealed the decision to CDER. As indicated above, CDER yesterday reaffirmed the FDA’s position.

LX9211

•Lexicon announced positive topline Phase 1 data for LX9211 in a multiple ascending dose study in healthy volunteers that demonstrated a favorable safety and pharmacokinetics profile supportive of once-daily dosing.

Fourth Quarter and Full-Year 2019 Financial Highlights

Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2019 compared to the fourth quarter and full year of 2018.

Revenues: Revenues for the fourth quarter decreased to $8.7 million from $17.1 million for the corresponding period in 2018, primarily due to lower revenues recognized under collaboration and license agreements. Full-year 2019 revenues increased to $322.1 million from $63.2 million, primarily due to collaboration revenues recognized from the termination of the alliance with Sanofi and recognition of remaining amounts allocated to the performance obligations from the initial Sanofi collaboration agreement for development activities relating to sotagliflozin, as well as an increase from net product revenue. Net product revenues for full-year 2019 included $31.0 million and $1.3 million, respectively, from net sales of XERMELO in the U.S. and the sale of bulk tablets to Lexicon’s collaborator, Ipsen.

Cost of Sales: Cost of sales related to sales of XERMELO was $0.7 million and $0.6 million, respectively, for the fourth quarter of 2019 and 2018. Full-year 2019 and 2018 cost of sales was $3.2 million and $2.5 million, respectively.

Research and Development (R&D) Expenses: Research and development expenses for the fourth quarter increased to $40.6 million from $12.3 million for the corresponding period in 2018, primarily due to increases in external clinical development costs relating to sotagliflozin subsequent to Lexicon regaining the rights and responsibilities for development and commercialization of sotagliflozin pursuant to the termination of the Sanofi alliance. Full-year R&D expenses for 2019 decreased to $91.9 million from $100.2 million, due to decreases in professional and consulting fees and lower external clinical development costs.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the fourth quarter were $14.6 million compared to $16.6 million for the same period in 2018. Full-year 2019 SG&A expenses decreased to $56.8 million from $63.8 million, primarily due to lower marketing expenses and professional and consulting costs.

Impairment Loss on Intangible Asset: An impairment loss in 2019 of $28.6 million was recognized to an indefinite lived intangible asset associated with Lexicon’s 2010 acquisition of Symphony Icon, due to the decision to terminate research and development activities related to a program for irritable bowel syndrome that was among the assets acquired.

Income Tax Benefit: An income tax benefit of $6.0 million in 2019 was recognized in connection with the impairment loss on the indefinite lived intangible asset, which resulted in a decrease to the deferred tax liability and created an income tax benefit. During 2018, there was no income tax benefit.

Net Income (Loss): Net loss for the fourth quarter was $51.1 million, or $0.48 per share, as compared to a net loss of $16.8 million, or $0.16 per share, in the corresponding period in 2018. For the fourth quarter 2019, net loss included non-cash, stock-based compensation expense of $3.5 million. For the fourth quarter 2018, net loss included non-cash, stock-based compensation expense of $2.8 million. Net income for the full-year 2019 was $130.1 million, or $1.16 per diluted share, as compared to a net loss of $120.5 million, or $1.14 per share, in 2018. For the full-year 2019, net income included non-cash, stock-based compensation expense of $14.2 million. For the full-year 2018, net loss included non-cash, stock-based compensation expense of $11.7 million.

Cash and Investments: As of December 31, 2019, Lexicon had $271.7 million in cash and investments, as compared to $160.1 million as of December 31, 2018.

Anticipated Near-Term Milestones

•H1 2020 – Initiation of a Phase 2 study for LX9211 in diabetic peripheral neuropathic pain
•H1 2020 – Completion of patient enrollment in the first efficacy cohort of the Phase 2 study of telotristat ethyl in biliary tract cancer
•H1 2020 – Topline results from core Phase 3 sotagliflozin studies in type 2 diabetes
•June 2020 – Presentation of Phase 3 data for sotagliflozin in type 2 diabetes at the 80th Scientific Sessions of the American Diabetes Association (ADA)
•September 2020 – Presentation of Phase 3 data for sotagliflozin in type 2 diabetes at the 56th Annual Meeting of the European Association for the Study of Diabetes (EASD)
•Q4 2020 – Data from the first efficacy cohort of the Phase 2 study of telotristat ethyl in biliary tract cancer

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 4187725. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

About XERMELO (telotristat ethyl)

Discovered using Lexicon’s unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. We are commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

XERMELO (telotristat ethyl) Important Safety Information

•Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
•Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
•Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

About Zynquista (sotagliflozin)

Discovered using Lexicon’s unique approach to gene science, Zynquista 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. Zynquista 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. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

On March 12, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (Press release, Hoffmann-La Roche, MAR 12, 2020, View Source [SID1234555456]).

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"Venclyxto plus Gazyvaro is the first fixed-duration, chemotherapy-free treatment option that has been shown to help patients with untreated chronic lymphocytic leukaemia live longer without their disease progressing," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "This is an important step forward for adults with this disease in the EU, who will now have an effective treatment option that enables them to end treatment after one year."

The approval is based on results from the primary analysis of the pivotal phase III CLL14 study, which evaluated the combination of 12-month, fixed-duration Venclyxto plus Gazyvaro compared to Gazyvaro plus chlorambucil in adults with previously untreated CLL who had co-existing medical conditions. Results from the primary analysis showed that the combination of Venclyxto plus Gazyvaro led to a 65% reduction in the risk of disease worsening or death (progression-free survival [PFS], as assessed by investigators) compared to Gazyvaro plus chlorambucil, a current standard-of-care for CLL (HR=0.35; 95% CI 0.23-0.53; p<0.0001). When PFS was assessed by an independent review committee, this finding was confirmed. Venclyxto plus Gazyvaro also showed higher response rates (ORR), doubled the complete response rates (CR/CRi) and demonstrated higher rates of minimal residual disease (MRD)-negativity, meaning that no cancer can be detected using a specific and highly sensitive test. In peripheral blood, MRD-negativity rates were 76% for Venclyxto plus Gazyvaro versus 35% for Gazyvaro plus chlorambucil, and in bone marrow MRD-negativity rates were 57% versus 17%, respectively. Results from an updated efficacy analysis (with a median follow-up of 40 months) were consistent with the primary data, and showed that the combination reduced the risk of disease worsening or death by 69% compared to Gazyvaro plus chlorambucil (HR=0.31; 95% CI 0.22-0.44). Safety for Venclyxto plus Gazyvaro appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. The most commonly reported adverse events in people treated with Venclyxto plus Gazyvaro were low white blood cell count (neutropenia), diarrhoea and upper respiratory tract infection.

Results from the CLL14 study further demonstrate Venclyxto’s potential across multiple lines (in the R/R and the frontline settings) in CLL. Previously, the European Commission has approved Venclyxto in combination with MabThera (rituximab) for the treatment of adults with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of CLL in the presence or absence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor. The US Food and Drug Administration (FDA) approved Venclexta in combination with Gazyva for the treatment of people with previously untreated CLL with co-existing medical conditions in May 2019. This followed rapid review and approval of the supplemental New Drug Application under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programmes. Additional submissions of the data to health authorities around the world are still ongoing, with the goal of bringing this new treatment option to more patients as soon as possible.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, under the brand name Venclexta, and commercialised by AbbVie outside of the US.

About the CLL14 study1
CLL14 (NCT02242942) is a randomised phase III study evaluating the combination of fixed-duration Venclyxto plus Gazyvaro compared to Gazyvaro plus chlorambucil in adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions. 432 patients with previously untreated CLL were randomly assigned to receive either a 12-month duration of Venclyxto alongside six-month duration of Gazyvaro (Arm A) or six-month duration of Gazyvaro alongside 12-month duration of chlorambucil (Arm B). Arm A started with an initial dosing of Gazyvaro followed by a five-week Venclyxto dose ramp-up to help reduce the risk of tumour lysis syndrome. The primary endpoint of the study is investigator-assessed (INV) progression-free survival (PFS). Secondary endpoints include PFS assessed by independent review committee (IRC), minimal residual disease (MRD) status, overall response rate (ORR), complete response rate (CR, with or without complete blood count recovery), overall survival, duration of response, event-free survival, time to next CLL treatment, and safety. MRD-negativity means no cancer can be detected using a specific, highly sensitive test, and was defined as less than one cancer cell in 10,000 leukocytes. The CLL14 study is being conducted in cooperation with the German CLL Study Group, headed by Michael Hallek, MD, University of Cologne.

CLL14 study primary analysis results2
Treatment arm Venclyxto + Gazyvaro
(n=216) Gazyvaro + chlorambucil
(n=216)
INV-assessed PFS (primary endpoint)
Median PFS Not reached Not reached
Hazard ratio 0.35 (95% CI 0.23-0.53), p<0.0001
Additional efficacy results (secondary endpoints)
IRC-assessed PFSa
Median PFS Not reached Not reached
Hazard ratio 0.33 (95% CI 0.22-0.51), p<0.0001
Response rates
ORR 85% 71%
CR + complete remission with incomplete bone marrow recovery (CRi) 50% 23%
MRDb
MRD-negative, bone marrow, 57% 17%
p-value p<0.0001
MRD-negative, peripheral blood, 76% 35%
p-value p<0.0001
Safety
Adverse events The most common adverse reactions (≥20%) with Venclyxto plus Gazyvaro were low white blood cell count (neutropenia), diarrhoea and upper respiratory tract infection. The most common serious adverse events in people treated with Venclyxto plus Gazyvaro were febrile neutropenia, pneumonia, infusion-related infection and pyrexia.
a Data at median follow-up of 28 months
b Data at three months following end of combination treatment, in the intention-to-treat population

About Venclyxto (venetoclax)
Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, under the brand name Venclexta, and commercialised by AbbVie outside of the US. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood and other cancers.

In the US, Venclexta has been granted five Breakthrough Therapy Designations by the US Food and Drug Administration: one for previously untreated chronic lymphocytic leukaemia (CLL), two for relapsed or refractory CLL and two for previously untreated acute myeloid leukaemia.

About Gazyvaro (obinutuzumab)
Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B-cells, but not on stem cells or plasma cells. Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system. Gazyvaro is marketed as Gazyva in the US.

Gazyva/Gazyvaro is currently approved in more than 90 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia, in more than 80 countries in combination with bendamustine for people with certain types of previously treated follicular lymphoma and in more than 70 countries in combination with chemotherapy for previously untreated follicular lymphoma.

Additional combination studies investigating Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

About chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the Western world.3 CLL mainly affects men and the median age at diagnosis is about 70 years.4 Worldwide, the incidence of all leukaemias is estimated to be over 400,000, with an incidence of over 100,000 in Europe.5 CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia.3

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies targeting both CD20 and CD3, Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

On March 12, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported that Merck, known as MSD outside the U.S. and Canada, has extended the research term of the collaboration’s first cytokine-derivative program by one year, which includes a payment to Sutro of an undisclosed amount (Press release, Sutro Biopharma, MAR 12, 2020, View Source [SID1234555455]). Sutro’s collaboration with Merck was announced in July 2018 to develop therapeutics for cancer and autoimmune disorders.

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"At Sutro, our proprietary and integrated cell-free protein synthesis and site-specific conjugation platform XpressCF+ enables us to design and develop next-generation targeted product candidates by innovating beyond the constraints of cell-based systems," said Sutro CEO, Bill Newell. "The advancement of our novel cytokine-derivative product candidate towards IND-enabling studies marks another important step forward in our collective goal of improving the outcomes for cancer patients."

"In all three of our current collaborations, and in three distinct therapeutic protein formats, we have progressed product candidates either into clinical development or to the late stages of preclinical development," said Sutro Chief Scientific Officer, Trevor Hallam, PhD. "These successes with Merck and with each of our other collaborators demonstrate the power and agility of our rapid and precise engineering platform."

On March 12, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the pricing of an underwritten public offering of 8,333,334 ordinary shares at a price to the public of $9.00 per share (Press release, Compugen, MAR 12, 2020, View Source [SID1234555454]). The gross proceeds to Compugen from the offering are expected to be approximately $75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Compugen. In addition, Compugen has granted the underwriters a 30-day option to purchase up to an additional 1,250,000 ordinary shares, at the public offering price less underwriting discounts and commissions. The offering is expected to close on or about March 16, 2020, subject to customary closing conditions.

SVB Leerink and Stifel are acting as joint bookrunning managers for the offering. SunTrust Robinson Humphrey is acting as lead manager for the offering and Oppenheimer & Co. is acting as co-manager for the offering.

The securities described above are being offered by Compugen pursuant to a shelf registration statement on Form F-3, including a base prospectus, that was previously filed by Compugen with the Securities and Exchange Commission (the "SEC") and that was declared effective on August 12, 2019. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at +1(800) 808-7525, ext. 6218, or by email at [email protected], or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at +1(415) 364-2720 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

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On March 12, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab [PD-1] in combination with zalifrelimab [CTLA-4] for the treatment of patients with relapsed or refractory metastatic cervical cancer (Press release, Agenus, MAR 12, 2020, View Source [SID1234555452]). This designation was based on comprehensive data that support the potential for balstilimab and zalifrelimab to address a significant unmet medical need. Agenus expects to file 2 BLAs this year for accelerated approval of the combination of balstilimab and zalifrelimab and balstilimab monotherapy in metastatic cervical cancer.

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"We are pleased that balstilimab and zalifrelimab have been granted Fast Track designation by FDA in recognition of the high unmet medical need in second line cervical cancer. The Fast Track designation confers important benefits, including the potential eligibility for a Priority Review," said Dr. Jennifer Buell, President and COO, Agenus. "We are excited about the prospect of making these novel agents available to women who suffer from metastatic cervical cancer. We look forward to continuing to work with FDA as we advance new treatment options for patients with cancer."

Agenus has reported updated data from a pre-planned interim analysis revealing robust and durable activity of balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer. The data demonstrated 26.5% objective response rates (ORR) (4 CRs, 5 PRs, 8 SD) which are durable (median not yet reached) in an all-comer, non-biomarker selected population of patients with refractory cervical cancer who have failed prior platinum chemotherapy with or without bevacizumab.

Fast Track designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a Biologic Licensing Application (BLA).