On November 7, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported financial results for the third quarter ending September 30, 2019 and provided a business update (Press release, Savara, NOV 7, 2019, View Source [SID1234550793]).

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"Based on the totality of evidence, we continue to believe that Molgradex has a clinically meaningful treatment effect on aPAP and we are committed to this program," said Rob Neville, Chief Executive Officer, Savara. "In the near-term, gaining clarity on the best regulatory path forward is our highest corporate priority and we look forward to further collaborating with the FDA and EMA in this regard."

Recent Developments and Upcoming Highlights

Molgradex for aPAP

Announced U.S. Food and Drug Administration (FDA) feedback from Type C meeting that indicated the data included in the briefing package did not provide sufficient evidence of efficacy and safety.
Working in consultation with the FDA to determine the best regulatory path forward for the program.
Presented efficacy and safety results from IMPALA, a Phase 3 study evaluating Molgradex for the treatment of aPAP, at the European Respiratory Society (ERS) International Congress. (Slides from the meeting can be found here.)
Expect to announce data from the open-label follow-up period of IMPALA (weeks 24-48) in Q1 2020.
Plan to initiate discussions with the European Medicines Agency (EMA) regarding the suitability of the IMPALA data for a potential Marketing Authorization Application (MAA).
Molgradex for nontuberculous mycobacterial (NTM) lung infection

Continue to expect top line results from OPTIMA, a Phase 2a clinical study evaluating Molgradex for the treatment of NTM in non-cystic fibrosis (CF) patients, in Q1 2020.
AeroVanc

Anticipate enrollment completion for AVAIL, a pivotal Phase 3 clinical study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF, in the first half of 2020 with top line results expected in late 2020 or early 2021.
As of November 1, 2019, the study had completed enrollment in the adult population and had enrolled 123 out of a target of 150 patients in the primary analysis population (younger subjects between 6-21 years of age).
Third Quarter Financial Results (Unaudited)

Savara’s net loss attributable to common stockholders for the three months ended September 30, 2019 was $12.4 million, or $(0.30) per share, compared with a net loss attributable to common stockholders of $12.6 million, or $(0.36) per share, for the three months ended September 30, 2018.

Research and development expenses were $9.6 million for the three months ended September 30, 2019, compared with $9.5 million for the three months ended September 30, 2018. The increase was primarily due to approximately $0.6 million in increased costs associated with the development of Molgradex, which was offset by $0.5 million in decreased AeroVanc study costs related to Phase 3 activities.

General and administrative expenses for the three months ended September 30, 2019 were $2.8 million, compared with $3.1 million for the three months ended September 30, 2018. The decrease was primarily due to an approximately $0.6 million noncash stock-based compensation charge incurred in the third quarter of 2018 offset in part by $0.2 million increased personnel costs for the three months ended September 30, 2019.

As of September 30, 2019, Savara had a carrying value of its debt of approximately $25.0 million and had cash, cash equivalents, and short-term investments of approximately $106.3 million. Under the current operating plan, the Company believes this is sufficient capital to fund planned operations well into 2021.

Conference Call/Webcast with Slides

Savara management will host a conference call/webcast with accompanying slides at 4:30 p.m. Eastern Time (ET) / 1:30 p.m. Pacific Time (PT). Shareholders and other interested parties may access the call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and requesting the "Savara Inc." call. A live webcast of the call can be accessed on the Investors page of Savara’s website at View Source

Approximately one hour after the call, a telephone replay will be available and will remain available through November 14, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10135923. A webcast replay will be available on the Investors page of Savara’s website and will remain available for 30 days.

On November 7, 2019 Eisenhower Health reported a revolutionary robot can now detect lung cancer at an early stage allowing for more-accurate diagnosis, changing the prognosis for many now diagnosed with the #1 cancer killer worldwide for both men and women (Press release, Eisenhower Health, NOV 7, 2019, View Source [SID1234550848]). Monarch Platform by Auris Health, Inc. has changed the medical detection landscape by viewing inside the lungs and obtaining a tissue sample for biopsy, enabling earlier and more-accurate analysis of small and hard-to-reach nodules in the periphery of the lung. Renowned Eisenhower Health (View Source) in Rancho Mirage, California is one of the first in the U.S., and one of the first in Southern California to now offer this new innovative and state-of-the-art technology in the fight against lung cancer, the #1 cancer killer today.

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Monarch Platform, recently cleared by the U.S. Food and Drug Administration (FDA), integrates the latest advancements in robotics, software, micro-instrumentation, sensing, data science and endoscopy into one platform to improve outcomes and reduce cost. This technology leverages the power of flexible robotics to enable new possibilities in endoscopy, using small cameras and tools to enter the body through its natural openings. It is intended for diagnostic and therapeutic bronchoscopic procedures.

"Lung cancer is now the leading cause of cancer deaths worldwide, in part because it has no symptoms in it’s early stages. This provides improved reach, vision and control for bronchoscopic procedures and is a very important piece of technology that now provides physicians continuous bronchoscope vision throughout the procedure leading to earlier detection, better outcomes, and a more hopeful future for patients," says Justin Thomas, MD, Board Certified Internal Medicine, Pulmonary Disease and Critical Care Medicine and Director of the Bronchoscopy Laboratory at Eisenhower Health.

News Facts:

Lung cancer is #1 global leading cause of cancer-related deaths for both men and women according to the American Cancer Society
Although the disease is rare among those under the age of 45, more people die from lung cancer than from colon, breast and prostate cancers combined, for both smokers and non-smokers, however, the risks are much greater for smokers
More than 90% of people diagnosed with lung cancer do not survive, often due to detection at an advanced stage
A variety of diagnostic options are currently available for lung cancer but all have limitations in accuracy, safety, or invasiveness. Limitations can lead to false positives, false negatives, or side effects such as pneumothorax (collapsed lung) and hemorrhage, which may increase health care costs and extend hospital stays
Monarch Platform was made possible to Eisenhower Health through a generous donation from Circle of Stars, a group of all female philanthropists established by Eisenhower Health’s Foundation.

On November 7, 2019 Eli Lilly and Company (NYSE: LLY) reported the early tender results for its previously announced cash tender offer of its outstanding debt securities (Press release, Eli Lilly, NOV 7, 2019, View Source [SID1234550603]). Lilly also announced that it had increased the previously announced tender cap from $2,000,000,000 to $2,000,006,000 aggregate principal amount of its debt securities, subject to further increase in its sole discretion. Except as described in this press release, all other terms of the tender offer as described in the Offer to Purchase, dated October 24, 2019, and the related Letter of Transmittal remain unchanged.

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$3,479,144,000 in aggregate principal amount of the notes listed in the table below were validly tendered and not validly withdrawn on or prior to 5:00 p.m., New York City time, on November 6, 2019, the early tender date for the offer. The table below sets forth the aggregate principal amount of each series of notes subject to the tender offer that were validly tendered and not validly withdrawn on or prior to the early tender date.

(1) The maximum principal amount of 3.950% Notes due 2049 that will be purchased by Lilly is $200,000,000.

(2) The maximum principal amount of 4.150% Notes due 2059 that will be purchased by Lilly is $200,000,000.

(3) The maximum principal amount of 2.350% Notes due 2022 that will be purchased by Lilly is $250,000,000.

Subject to the conditions in the Offer to Purchase, Notes validly tendered and not validly withdrawn at or prior to the early tender date with Acceptance Priority Level 11 have been accepted for purchase using a proration factor of approximately 52.8%.

The settlement date for the notes accepted by Lilly in connection with the early tender date currently is expected to be on November 8, 2019.

Lilly expects to determine the pricing terms of the tender offer at 10:00 a.m., New York City time, on November 7, 2019. The tender offer is scheduled to expire at 11:59 p.m., New York City time, on November 21, 2019, unless extended or earlier terminated.

Holders of notes subject to the tender offer who validly tendered and did not validly withdraw their notes on or prior to the early tender date are eligible to receive the total consideration, which includes an early tender premium of $30 per $1,000 principal amount of notes tendered by such holders and accepted for purchase by Lilly. Accrued interest up to, but not including, the settlement date will be paid in cash on all validly tendered notes accepted and purchased by Lilly in the tender offer.

In accordance with the terms of the tender offer, the withdrawal date was 5:00 p.m., New York City time, on November 6, 2019. As a result, tendered notes may no longer be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

The tender offer is being conducted upon the terms and subject to the conditions set forth in the Offer to Purchase, dated October 24, 2019, and the related Letter of Transmittal, as supplemented by this press release.

Lilly has retained Citigroup Global Markets Inc. and Morgan Stanley & Co. LLC to serve as lead dealer managers for the tender offer and BNP Paribas Securities Corp. and J.P. Morgan Securities LLC to serve as co-dealer managers. Lilly has retained Global Bondholder Services Corporation to serve as tender agent and information agent for the tender offer.

Requests for documents relating to the tender offer may be directed to Global Bondholder Services Corporation by telephone at (866) 470-3900, by email at [email protected] or in writing at 65 Broadway, Suite 404, New York, NY 10006. Questions regarding the tender offer may be directed to Citigroup Global Markets Inc. at (212) 723-6106 or to Morgan Stanley & Co. LLC at (800) 624-1808.

This press release is for informational purposes only and is not a tender offer to purchase or a solicitation of acceptance of a tender offer, which may be made only pursuant to the terms of the Offer to Purchase. In any jurisdiction where the laws require the tender offer to be made by a licensed broker or dealer, the tender offer will be deemed made on behalf of Lilly by the dealer managers, or one or more registered brokers or dealers under the laws of such jurisdiction. In addition, this press release is not an offer to sell or the solicitation of an offer to buy any securities. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any such securities will be offered only by means of a prospectus, including a prospectus supplement relating to such securities, meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

On November 7, 2019 Sophiris Bio Inc. (NASDAQ: SPHS), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported financial results for the third quarter 2019 and provided an overview of recent corporate highlights (Press release, Sophiris Bio, NOV 7, 2019, View Source [SID1234550633]).

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"We took a significant step forward with the agreement of a Phase 3 trial design with the FDA for our localized prostate cancer program, a step that advances discussions around potential strategic agreements necessary to help fund the development of topsalysin", said Randall E. Woods, president and CEO of Sophiris. "The design agreed to with the FDA aligns with the design previously approved by the EMA which will allow us to complete a global Phase 3 program for the potential approval of topsalyin for treating patients with intermediate risk localized prostate cancer in both the US and Europe."

Recent Corporate Highlights:

On August 30, 2019, the Company announced the closing of a registered offering in which the Company raised net proceeds of $3.6 million. This support from a new investor provides the company additional financial resources to execute on a funding strategy for the Phase 3 localized prostate cancer study. The company estimates that the cash and cash equivalents currently on hand will fund the Company through at least March 31, 2020.

On October 21, 2019, the Company announced that following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer. The Phase 3 study design agreed upon with the FDA is consistent with the design previously agreed upon with the EMA. In addition, the FDA has indicated that in order to receive approval, we will need to evaluate all patients that progress to alternative treatments for an additional 12 months, for a total of 24 months of data, post the administration of the study drug. The Company believes that a single Phase 3 trial, if successful, will provide the clinical data necessary for approval in both the United States and Europe.

From November 10-13, 2019, Sophiris CEO Randall E. Woods will attend the 25th Annual International Partnering Conference Bio-Europe 2019.

Financial Results:

At September 30, 2019, the Company had cash, cash equivalents and securities available-for-sale of $6.3 million and working capital of $3.1 million. The Company expects that its cash and cash equivalents and securities available-for-sale will be sufficient to fund its operations and debt service through March 2020, assuming no new clinical trials are initiated and the Company continues operating as a going concern. The Company will require significant funding to advance topsalysin in clinical development and to continue its operations. As of September 30, 2019, the outstanding principal balance of the Company’s term loan was $5.6 million. The Company began making principal payments on its term loan in April 2019.

For the three months ended September 30, 2019

The Company reported a net loss of $1.0 million or ($0.03) per share for the three months ended September 30, 2019, compared to net loss of $2.9 million or ($0.10) per share for the three months ended September 30, 2018.

Research and development expenses

Research and development expenses were $0.7 million for the three months ended September 30, 2019, compared to $1.8 million for the three months ended September 30, 2018. The decrease in research and development costs is primarily attributable to decreases in the costs associated with manufacturing activities for topsalysin and, to a lesser extent, a decrease in clinical costs associated with the Company’s completed Phase 2b clinical trial of topsalysin for localized prostate cancer.

General and administrative expenses

General and administrative expenses were $1.4 million for the three months ended September 30, 2019, compared to $1.2 million for the three months ended September 30, 2018. Included as a component of general and administrative expense for the three months ended September 30, 2019 was $0.4 million of offering costs which were allocated to the common share purchase warrants issued in its August 2019 financing. These offering costs were allocated to general and administrative expense as the common share purchase warrants were classified as liabilities. General and administrative expenses included non-cash stock-based compensation expense of $0.1 million for the three months ended September 30, 2019 as compared to $0.2 million for the three months ended September 30, 2018.

Gain on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $1.3 million for the three months ended September 30, 2019, compared to $0.2 million for the three months ended September 30, 2018. As the Company’s warrants may require the Company to pay the warrant holders cash under certain provisions of the warrants, the Company accounts for the warrants as a liability, and the Company is required to calculate the fair value of these warrants each reporting date. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in a material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.

For the nine months ended September 30, 2019

The Company reported a net loss of $5.5 million or ($0.18) per share for the nine months ended September 30, 2019 compared to a net loss of $12.3 million or ($0.41) per share for the nine months ended September 30, 2018.

Research and development expenses

Research and development expenses were $3.4 million for the nine months ended September 30, 2019 compared to $8.7 million for the nine months ended September 30, 2018. The decrease in research and development costs was primarily attributable to decreases in the costs associated with manufacturing activities for topsalysin, and to a lesser extent, a decrease in clinical costs associated with the Company’s completed Phase 2b clinical trial of topsalysin for localized prostate cancer.

General and administrative expenses

General and administrative expenses were $3.9 million for the nine months ended September 30, 2019 compared to $3.5 million for the nine months ended September 30, 2018. Included as a component of general and administrative expense for the nine months ended September 30, 2019 was $0.4 million of offering costs which were allocated to the common share purchase warrants issued in its August 2019 financing. These offering costs were allocated to general and administrative expense as the common share purchase warrants were classified as liabilities. General and administrative expenses included non-cash stock-based compensation expense of $0.4 million for the nine months ended September 30, 2019 as compared to $0.5 million for the nine months ended September 30, 2018.

Gain on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $2.1 million for the nine months ended September 30, 2019 as compared to $0.1 million for the nine months ended September 30, 2018.

On November 7, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Stifel 2019 Healthcare Conference on Tuesday, November 19, 2019 at 1:50 p.m. EST (Press release, Bio-Techne, NOV 7, 2019, View Sourcepress-releases/detail/166/bio-techne-to-present-at-the-2019-stifel-healthcare" target="_blank" title="View Sourcepress-releases/detail/166/bio-techne-to-present-at-the-2019-stifel-healthcare" rel="nofollow">View Source [SID1234550649]). The conference will be held at the Lotte New York Palace hotel in New York, NY. A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link View Source

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