On October 30, 2019 MannKind Corporation (NASDAQ:MNKD) reported that it will release its 2019 third quarter and year-to-date financial results and its management will host a conference call to discuss the financial results and corporate updates at 9:00 AM (Eastern Time) on Wednesday, November 6, 2019 (Press release, Mannkind, OCT 30, 2019, View Source [SID1234550042]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

To participate in the live call by telephone, please dial (866) 548-4713 or (323) 794-2093 and use the participant passcode: 8987532. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 8987532. A replay will also be available on MannKind’s website for 14 days.

On October 30, 2019 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the third quarter ended September 30, 2019 (Press release, Lpath, OCT 30, 2019, View Source [SID1234550041]).

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Third Quarter 2019 Highlights
•ESS sales increased 28% (30% in constant currency) to $6.7 million, representing 64% of our Endoscopy sales for the third quarter
•Endoscopy sales increased 12% (14% in constant currency) to $10.4 million
•Received 510(k) clearance from the FDA for the OverStitch Polypropylene Suture-Anchor Assembly
Todd Newton, CEO of Apollo, commented, "Strong market momentum for OverStitch continued in the third quarter with 28% increase in sales. This marks our fourth consecutive quarter of double-digit year-over-year growth in OverStitch sales. We remain enthusiastic about the opportunities ahead to continue this growth, driven by expansion of our user base and ongoing clinical investments that will continue to demonstrate the notable clinical benefits of our Endoscopy products."
Third Quarter 2019 Results
Consolidated Endoscopy product sales increased 12% as reported and 14% in constant currency. For the third quarter, 64% of Endoscopy product sales related to ESS. In the U.S., Endoscopy sales increased 30% to $4.8 million.
Worldwide, ESS product sales increased 28% as reported and 30% in constant currency. U.S. ESS product sales increased 48% to $3.7 million in the third quarter of 2019. Outside the US ("OUS") ESS product sales increased 9% as reported and 12% in constant currency to $2.9 million.
Worldwide IGB sales decreased 9% as reported and 7% on a constant currency basis. U.S. IGB sales decreased $0.1 million, or 7%, to $1.1 million in the third quarter of 2019 while OUS IGB product sales decreased 9% as reported and 7% on a constant currency basis to $2.6 million.
The divestiture of our Surgical products in December of 2018 reduced total revenues in the third quarter of 2019 by $3.9 million compared to the third quarter of 2018. We divested the Surgical products in order to strengthen the organization’s focus on our Endoscopy products, which we believe have high growth potential.
Gross margin for the third quarter 2019 was 48%, compared to 55% for the third quarter 2018 as a result of a greater proportion of our overall product sales coming from our ESS products, which realize a lower gross margin than our other products.
Total operating expenses decreased $3.6 million to $12.3 million in the third quarter 2019, compared to the third quarter 2018. Research and development expense declined $1.5 million compared with the third quarter of 2018 as we neared completion in certain of our clinical studies. In addition, amortization expense is $1.3 million lower as a result of the reduction in our intangible assets after the recent divestiture of our Surgical products.
Net loss for the third quarter 2019 was $8.7 million compared to $9.8 million for the third quarter 2018.
Cash, cash equivalents and restricted cash were $36.0 million as of September 30, 2019. The Company raised proceeds of $20.0 million from the issuance of convertible debt in August 2019.
Conference Call
Apollo will host a conference call on October 30, 2019 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss operating results for the third quarter ended September 30, 2019.
To participate in the conference call dial (877) 823-8673 for domestic callers and (647) 689-4156 for international callers. The conference ID number is 6392218. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.
A replay of the webcast will be made available on Apollo’s website, www.apolloendo.com following the event.

Non-GAAP Financial Measures
To supplement our financial results we are providing a non-GAAP financial measure, percentage revenue change in constant currency, which removes the impact of changes in foreign currency exchange rates that affect the comparability and trend of revenues. Percentage revenue change in constant currency is calculated by translating current foreign currency sales at last year’s exchange rate. This supplemental measure of our performance is not required by, and is not determined in accordance with GAAP.
We believe the non-GAAP financial measure included herein is helpful in understanding our current financial performance. We use this supplemental non-GAAP financial measure internally to understand, manage and evaluate our business, and make operating decisions. We believe that making non-GAAP financial information available to investors, in addition to GAAP financial information, may facilitate more consistent comparisons between the company’s performance over time with the performance of other companies in the medical device industry, which may use similar financial measures to supplement their GAAP financial information. However, our non-GAAP financial measure is not meant to be considered in isolation or as a substitute for the comparable GAAP metric.

On October 30, 2019 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the microbiome organ to treat disease and improve human health, reported financial results for the third quarter ended September 30, 2019, and provided a corporate update (Press release, Kaleido Biosciences, OCT 30, 2019, View Source [SID1234550040]).

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"Over the last two years we have invested in building our platform, including expanding our library of more than 1,500 MMTs and manufacturing capabilities. We have made important progress across the business, and today we have four ongoing clinical studies with three MMTs in three different patient populations, and presented encouraging data from a fifth study at the SSIEM meeting last month. We are also leveraging collaborations to advance our understanding of the potential of our MMTs in promising areas of health and disease where the microbiome is implicated, such as immuno-oncology," said Alison Lawton, President and Chief Executive Officer of Kaleido. "We are focusing our resources on our current pipeline, executing against key clinical milestones while optimizing our operational efficiencies to extend our cash runway. We anticipate results from our studies of KB174, including in patients with cirrhosis, during Q4 2019, and next year from our KB109 multi-drug resistant pathogens program and Phase 2 trial of KB195 in patients with urea cycle disorders."

Corporate Update and Anticipated Milestones

Dosing is underway in the Phase 2 trial (UNLOCKED) designed to evaluate KB195 in 18-24 patients with urea cycle disorders (UCD). Kaleido, in consultation with study investigators who are leaders in the clinical management of UCD patients, has elected to adjust the primary endpoint for this study in a rare orphan disease population to a within-patient responder analysis of the proportion of patients with ≥15 percent decrease in fasting plasma ammonia. The original primary endpoint, 24-hour area under the curve plasma ammonia, will be measured as a secondary endpoint. The Phase 2 trial was initiated approximately 24 months after conducting the first ex vivo screening, and data are expected in mid-2020.

Results from two clinical studies for Kaleido’s hepatic encephalopathy program evaluating KB174 in patients with well-compensated cirrhosis and in healthy volunteers are expected during Q4 2019.

Enrollment continues in the clinical study (VITORA) assessing KB109 in patients colonized with multi-drug resistant pathogens, and data are anticipated in mid-2020.

Kaleido is undertaking measures to focus resources on its pipeline programs, enhance operational efficiencies and extend its cash by approximately a quarter with runway into Q4 2020. This includes decreasing manufacturing and other external costs as well as reducing headcount by approximately 25 percent.
Recent Highlights

Entered into a research collaboration with Jeffrey Gordon, M.D., Director of the Edison Family Center for Genome Sciences and Systems Biology at Washington University School of Medicine, to explore the influence of MMTs on microbial and host physiology and metabolism.

Announced a collaboration with Gustave Roussy, the largest cancer treatment center in Europe, to identify and characterize MMT candidates with the potential to improve cancer immunotherapy efficacy; the research program is aimed at increasing the number of patients who respond to inhibitors of immune checkpoints by changing their microbiome composition and metabolic output.

Presented data at the annual Society for the Study of Inborn Errors of Metabolism Symposium (SSIEM) from a clinical study of KB195 in patients with UCD which demonstrated safety and tolerability and potential for effect on nitrogen metabolism, a biomarker of ammonia production.

Presented at IDWeek 2019 ex vivo data showing that KB109 reduced the relative abundance of multi-drug resistant pathogens in microbiome samples from two different populations at high risk for infection, patients in the intensive care unit who had received broad-spectrum antibiotics and patients with end-stage liver disease.

Presented ex vivo and in vivo data demonstrating the ability of MMTs to reduce toxic side effects of chemotherapy through multiple mechanisms at the Keystone Symposia on the Microbiome: Therapeutic Implications.
Third Quarter 2019 Financial Results

For the third quarter ended September 30, 2019, Kaleido reported a net loss of $22.0 million, or $0.74 per common share, compared to $17.4 million, or $3.38 per common share for the third quarter ended September 30, 2018.

In the third quarter of 2019, Kaleido invested $16.2 million in research and development (R&D) related to advancing its product pipeline, as compared to $10.2 million in the third quarter of 2018. This year-over-year increase was driven primarily by incremental R&D spending for KB195, including the Company’s Phase 2 clinical trial and external manufacturing. Additional incremental spend year-over-year related to ongoing clinical studies, including two clinical studies for Kaleido’s hepatic encephalopathy program evaluating KB174, and the VITORA clinical study of KB109 in multi-drug resistant pathogens.

General and administrative (G&A) expenses were $5.9 million during the third quarter of 2019, as compared to $7.1 million for the third quarter of 2018. This year-over-year decrease was driven primarily by lower stock-based compensation costs related to G&A.

Included in net loss was non-cash stock-based compensation expenses of $2.9 million for the third quarter of 2019, as compared to $3.8 million in the third quarter of 2018.

As of September 30, 2019, the Company reported cash and cash equivalents of $81.3 million.

About Microbiome Metabolic Therapies (MMT)

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome organ’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its human-centric discovery and development platform to study MMTs in microbiome samples in an ex vivo setting, followed by advancing MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.

On October 30, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its third quarter 2019 financial results and provided an update on the company, including its progress with IPI-549, a first-in-class oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition (Press release, Infinity Pharmaceuticals, OCT 30, 2019, View Source [SID1234550039]).

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"It is an exciting and important time for Infinity as we anticipate completing enrollment in MARIO-1 by the end of this year and presenting data from our MARIO-1 and MARIO-3 trials in 2020. During 2020 we also expect to complete enrollment in MARIO-275, our randomized, controlled Phase 2 trial in patients with bladder cancer," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "As we advance multiple studies designed to produce compelling data across a wide range of indications in innovative combinations, we are witnessing surging recognition of the importance of tumor macrophage-directed immuno-oncology therapies among the medical and scientific communities. With additional clinical and translational data expected from IPI-549 studies starting in 2020, Infinity is positioned to become the leader in macrophage-targeted immunotherapy."

Updated IPI-549 Clinical Program Guidance

MARIO-1 enrollment completion expected by year end with data presentation expected in 2020. MARIO-1 is the company’s ongoing Phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo in patients with advanced solid tumors.
MARIO-3 enrollment completion and data presentation expected in 2020. MARIO-3 is the company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq and Abraxane in triple negative breast cancer (TNBC) and with Tecentriq and Avastin in renal cell cancer (RCC).
MARIO-275 enrollment completion expected during 2020. MARIO-275 is the company’s global, randomized Phase 2 study in collaboration with Bristol-Myers Squibb, to evaluate IPI-549 in combination with Opdivo in platinum-refractory, I/O naïve patients with advanced urothelial (bladder) cancer.
Arcus Biosciences Collaboration Study Initiated: This Phase 1 trial, being conducted by Arcus, is evaluating a checkpoint-inhibitor free, novel triple-combination regimen of IPI-549 + AB928 (dual adenosine receptor antagonist) + Doxil in advanced TNBC patients.
Third Quarter 2019 Financial Results

At September 30, 2019, Infinity had total cash, cash equivalents and available-for-sale securities of $52.0 million, compared to $63.0 million at June 30, 2019.
Research and development expense for the third quarter of 2019 was $7.1 million, compared to $5.4 million for the same period in 2018. The increase in R&D expense was primarily due to an increase in clinical and development activities for IPI-549.
General and administrative expense was $3.6 million for the third quarter of 2019, compared to $3.4 million for the same period in 2018.
Net loss for the third quarter of 2019 was $11.4 million, or a basic and diluted loss per common share of $0.20, compared to net income of $13.4 million, or a basic and diluted earnings per common share of $0.23 for the same period in 2018. In the third quarter of 2018, we recognized $22.0 million in revenue related to a one-time payment due from Verastem for the approval by the U.S. Food and Drug Administration of Copiktra, which Infinity licensed to Verastem in 2016.
2019 Financial Guidance

Net Loss: Infinity expects net loss for 2019 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2019 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $40 million to $50 million.
Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company’s capital needs for at least the next 12 months. Infinity’s financial guidance excludes additional funding or business development activities.
Conference Call Information

Infinity will host a conference call today, October 30, 2019, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 2612978. An archived version of the webcast will be available on Infinity’s website for 30 days.

On October 30, 2019 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the third quarter of 2019 (Press release, Immunomedics, OCT 30, 2019, View Source [SID1234550038]). Please refer to the Company’s Quarterly Report on Form 10-Q for more details on the Company’s financial results.

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"We have made significant progress over the past nine months against important manufacturing and clinical milestones, while seeking opportunities to unlock value for sacituzumab govitecan through potential new indications and new geographies. As a result of the hard work put forth by our quality, manufacturing, and clinical/regulatory teams, we are on target to submit our Biologics License Application (BLA) for sacituzumab govitecan in late-stage metastatic triple-negative breast cancer (mTNBC) in patients who have received at least two prior therapies for metastatic disease to the FDA in late November or early December, 2019. Furthermore, we are continuing our preparations and expect to be well-positioned for a pre-approval inspection following our resubmission," stated Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics.

In the quarter, the Company reported interim results from the Phase 2 open-label study, of sacituzumab govitecan in patients with metastatic urothelial cancer (mUC) (TROPHY-U-01) at the ESMO (Free ESMO Whitepaper) 2019 Congress. The results from the initial 35 cisplatin-eligible patients were highly consistent with the previously-established clinical activity and safety profile of sacituzumab govitecan and are encouraging relative to standard of care in this setting. The target enrollment of 100 patients in this cohort was reached in early October, ahead of the year-end 2019 plan. "We are pleased to have accomplished these two important goals and look forward to discussing the registrational path forward for sacituzumab govitecan in mUC with the FDA," added Dr. Aghazadeh.

The Company has also expanded the clinical development of sacituzumab govitecan to additional metastatic solid tumors with the newly-opened multi-cohort, open-label, Phase 2 TROPiCS-03 study having dosed the first patient with non-small cell lung cancer (NSCLC). This is the first study conducted by Immunomedics in which a biomarker will be used to assess whether enrichment for Trop-2 expression may lead to higher responses in certain indications.

In the quarter, the Company entered into two important clinical collaborations to potentially advance sacituzumab govitecan to earlier lines of breast cancer treatment. While the collaboration with Roche will develop sacituzumab govitecan in the frontline setting of mTNBC by combining it with Roche’s programmed cell death ligand 1 (PD-L1)-blocking checkpoint inhibitor, atezolizumab (Tecentriq), the German Breast Group (GBG) will conduct a multinational Phase 3 study in the curative setting for high-risk patients with human epidermal growth factor receptor 2-negative (HER2–) breast cancer who do not achieve a pathological complete response (pCR) following standard neoadjuvant therapy.

"As we get closer to resubmission, the Company will continue to accelerate its efforts towards commercial launch readiness. We have maintained a significant portion of our U.S. commercial infrastructure through a creative and productive arrangement with Janssen, and will continue to bolster our capabilities to ensure a successful launch," added Dr. Aghazadeh.

Recent Company Highlights

At the ESMO (Free ESMO Whitepaper) 2019 Congress, the Company presented interim data from the open-label Phase 2 TROPHY-U-01 study that showed an overall response rate of 29 percent, including two confirmed complete responses, six confirmed partial responses (PRs) and two additional PRs pending confirmation, in 35 patients with metastatic urothelial cancer who had relapsed or were refractory to immune checkpoint inhibitors (CPI) and platinum-based chemotherapy. This study has now reached target enrollment of 100 platinum-eligible patients who have progressed after prior CPI and platinum-based therapies.

The Company announced a clinical collaboration with Roche to evaluate the safety and efficacy of combining sacituzumab govitecan with atezolizumab (Tecentriq), Roche’s PD-L1-blocking checkpoint inhibitor, as a frontline treatment of patients with metastatic or inoperable locally advanced TNBC. Patients with newly-diagnosed mTNBC will be randomized to receive the combination of atezolizumab and sacituzumab govitecan or nab-paclitaxel plus atezolizumab as standard of care. Roche will be responsible for conducting this randomized study.

In addition, the Company and GBG have entered into a collaboration to develop sacituzumab govitecan as a potential treatment for patients with HER2– breast cancer in the curative setting. The multinational, post-neoadjuvant Phase 3 SASCIA study will be conducted under the sponsorship of GBG and enroll approximately 1,200 high-risk patients with HER2– breast cancer who do not achieve a pCR following standard neoadjuvant therapy. Patients will be randomized to receive either sacituzumab govitecan or treatment of physician’s choice.

In the open-label, Trop-2-enriched multi-cohort Phase 2 TROPiCS-03 study (NCT03964727), the first patient with NSCLC has been dosed. The primary endpoint of this study is overall response rate with duration of response and progression-free survival serving as secondary endpoints.
Third Quarter and Nine Months 2019 Financial Results

The Company had no revenues for the quarter and nine months ended September 30, 2019, due primarily to the discontinued sale of LeukoScan in February 2018 in order for the Company to focus on its ADC business. Revenues in the comparable nine months ended September 30, 2018 was $0.9 million.

Total costs and expenses were $86.8 million for the quarter and $233.6 million for the nine months ended September 30, 2019, compared to $57.2 million for the comparable quarter and $148.1 million for the nine months ended September 30, 2018. The increases were due primarily to increased expenses in research and development and sales and marketing, partially offset by decreases in general and administrative expenses. The increases in research and development costs were mostly attributable to activities related to preparations for the approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for mTNBC in the United States and expanded clinical development of sacituzumab govitecan into other indications.

The Company had no non-cash warrant-related income or expense for the quarter and nine months ended September 30, 2019, compared a $1.2 million of non-cash gain for the comparable quarter and a $47.8 million warrant-related expense for the nine months ended September 30, 2018, due to changes in the fair value of then outstanding warrants. There were no warrants outstanding as of September 30, 2019 and December 31, 2018.

Interest expense was $9.7 million for the quarter and $30.3 million for the nine months ended September 30, 2019, compared to $10.1 million for the comparable quarter and $30.5 million for the nine months ended September 30, 2018. The decreases were due primarily to changes in the fair value of our debt balances as a result of the agreement with RPI Finance Trust.

Net loss attributable to stockholders was $94.3 million, or $0.49 per share, for the quarter ended September 30, 2019, compared to $64.2 million, or $0.34 per share, for the comparable quarter ended September 30, 2018. Net loss attributable to stockholders was $257.6 million, or $1.34 per share, for the nine months ended September 30, 2019, compared to $216.7 million, or $1.24 per share, for the nine months ended September 30, 2018.

As of September 30, 2019, the Company had $369.2 million in cash, cash equivalents, and marketable securities. The Company believes this amount is adequate to support its clinical development plan for sacituzumab govitecan, further build its clinical and manufacturing infrastructure and fund its operations through 2020.

Conference Call

The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss third quarter 2019 financial results and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 3164368. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.