On November 10, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the third quarter and nine months ended September 30, 2021, and provided a corporate update (Press release, Lipocine, NOV 10, 2021, View Source [SID1234595156]).

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Third Quarter and Recent Corporate Highlights

Entered into a license agreement with Antares Pharma to commercialize TLANDO in the US
Lipocine to receive up to $21.0 million in licensing fees, including $11.0 million payable immediately and $10.0 million to be paid in the future subject to certain conditions
Lipocine is entitled to commercial sales milestone payments of up to $160.0 million and tiered royalties on net sales of TLANDO from mid-teens up to 20%
Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of TLANDO in the U.S.
Antares Pharma was also granted an option to license TLANDO XR for development and commercialization in the U.S. for additional licensing fees ($4.0 million), clinical and regulatory milestone payments ($35.0 million), sales milestone payments and royalties (mid-teens up to 20%)
The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis ("NASH")
The FDA has affirmed that the resubmission of the New Drug Application ("NDA") for TLANDO will be a Class 1 resubmission, with a two-month FDA review goal period
The FDA previously granted tentative approval to TLANDO in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
The product is not eligible for final approval and marketing in the U.S. until the expiration of the FDA’s Orange Book listed exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo, which expires on March 27, 2022
Announced positive topline 36-week results from its Phase 2 proof-of-concept Liver Fat intervention with oral Testosterone ("LiFT") clinical study, NCT04134091, investigating LPCN 1144 in men with biopsy-confirmed NASH
Study met its primary endpoint. At 12 weeks, treatment with LPCN 1144 resulted in statistically significant liver fat reduction, assessed by MRI-PDFF
Both LPCN 1144 treatment arms showed significant improvement in NASH without worsening of fibrosis
Efficacy and safety results from the LiFT study have been accepted for late-breaking presentations at the American Association for the Study of Liver Diseases ("AASLD") The Liver Meeting on November 12-15, 2021
Company intends to meet with the FDA regarding the path forward for an accelerated approval and to discuss Phase 3 study requirements
Third Quarter Ended September 30, 2021 Financial Results

Lipocine reported a net loss of $3.1 million, or ($0.03) per diluted share, for the third quarter ended September 30, 2021, compared with a net loss of $4.3 million, or ($0.07) per diluted share, for the third quarter ended September 30, 2020.

Research and development expenses were $2.4 million for the third quarter ended September 30, 2021, compared with $2.5 million for the third quarter ended September 30, 2020. The decrease for the third quarter of 2021 was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study as well as decrease costs related to TLANDO. These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs.

General and administrative expenses were $1.2 million for the third quarter ended September 30, 2021, compared with $1.9 million for the third quarter ended September 30, 2020. The decrease in general and administrative was primarily related to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense.

As of September 30, 2021, the Company had $38.7 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.

Subsequent to the end of the third quarter, the Company received an $11.0 million upfront license fee as part of the licensing agreement with Antares Pharma to commercialize TLANDO.

Nine Months Ended September 30, 2021 Financial Results

Lipocine reported a net loss of $13.3 million, or ($0.15) per diluted share, for the nine months ended September 30, 2021, compared with a net loss of $16.5 million, or ($0.32) per diluted share, for the nine months ended September 30, 2020.

Research and development expenses were $5.4 million for the nine months ended September 30, 2021, compared with $7.3 million for the nine months ended September 30, 2020. The decrease in research and development expenses was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study, a decrease in costs related to TLANDO and a decrease in personnel costs primarily related to reduced stock compensation expense. These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs.

General and administrative expenses were $4.3 million for the nine months ended September 30, 2021, compared with $5.9 million for the nine months ended September 30, 2020. The decrease in general and administrative expenses was primarily due to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense. These decreases were offset by an increase in corporate insurance expense.

On November 10, 2021 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported third quarter 2021 financial results and a corporate update (Press release, Ryvu Therapeutics, NOV 10, 2021, View Source [SID1234595155]).

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"In the third quarter Ryvu has achieved several important milestones for its proprietary pipeline programs", said Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.

"We are excited to announce the latest clinical and translational data for our most advanced project RVU120 at the upcoming ASH (Free ASH Whitepaper) and SABCS conferences, and our preclinical data on HPK1 and STING compounds at the SITC (Free SITC Whitepaper) conference in November. These encouraging data further reinforce the therapeutic potential of our programs, and we look forward to seeing how our discovery and research are translating into a tangible promise for cancer patients."

Recent Highlights

Two Poster Presentations of HPK1 and STING programs at SITC (Free SITC Whitepaper)’s 36th Annual Meeting
Ryvu will present a poster on novel, orally administered HPK1 inhibitors which exhibit nanomolar activity in an immunosuppressive environment. These small molecules have shown favorable PK profiles allowing for in vivo target engagement after oral administration, and hold promising potential as a treatment in a variety of solid tumor indications.

The second poster will highlight a novel small-molecule STING agonist, RVU-27065. Selective STING pathway activation with RVU-27065 allows for repolarization of immunosuppressive tumor-associated macrophages into a pro-inflammatory phenotype without a negative impact on T-cell functioning. With favorable drug-like properties and good safety profile, RVU-27065 is a promising candidate for standalone treatment as well as targeted delivery as a payload for antibodies.

Presentation of clinical and translational data from RVU120 and SEL24/MEN1703 at the 63rd "ASH" Annual Meeting & Exposition and the 44th Annual SABCS
On November 4, Ryvu announced that, together with its collaborators from MD Anderson Cancer Center and the Menarini Group, it will present six posters showing new data demonstrating clinical and preclinical activity of its selective CDK8/19 inhibitor RVU120 (SEL120) and selective PIM/FLT3 inhibitor SEL24 (MEN1703) during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition and at the 44th Annual San Antonio Breast Cancer Symposium (SABCS).

The posters to be presented include: initial data from ongoing Phase Ib of RVU120 which demonstrates an acceptable safety profile and early signs of efficacy, including a Complete Remission (CR) within the first five dose cohorts; an ongoing dose escalation in AML and HR-MDS; translational research for RVU120 demonstrated a strong trend of efficacy in DNMT3A-mutated AML patient-derived cells; preclinical models showing potential for clinical efficacy of RVU120 in breast cancer. Ryvu licensee, Menarini Group will be presenting SEL24/MEN1703 data from the first-in-human, dose-escalation and cohort expansion CLI24-001 trial.

Ryvu’s partner Menarini Group receives FDA Orphan Drug Designation for SEL24 (MEN1703) for the Treatment of Acute Myeloid Leukemia
On November 4, Menarini Group announced that the FDA has granted an ODD to SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor, in-licensed by Menarini Group from Ryvu. Currently SEL24/MEN1703 is being examined as part of the DIAMOND-01 trial as a single agent for the treatment of patients with AML. DIAMOND-01 is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24/MEN1703, investigated as a single agent for the treatment of patients with AML.

First patient dosed in Phase I/II study of RVU120 (SEL120) in patients with relapsed/refractory (R/R) metastatic or advanced solid tumors
On August 25, Ryvu announced that the first patient was dosed in the Phase I/II clinical trial investigating RVU120 in relapsed/refractory metastatic or advanced solid tumors. The single-agent, open-label Phase I/II trial is currently enrolling patients in Poland, and site expansion to Spain is in progress.

Publication of research on MCT4 inhibitors in the Journal of Medicinal Chemistry
On August 8, a joint publication of researchers from Ryvu Therapeutics and Merck KGaA on the discovery, development, and optimization of selective MCT4 inhibitors was published in the Journal of Medicinal Chemistry: "Discovery of 5-{2-[5-Chloro-2-(5-ethoxyquinoline-8-sulfonamido)phenyl]ethynyl}-4-methoxypyridine-2-carboxylic Acid, a Highly Selective in Vivo Useable Chemical Probe to Dissect MCT4 Biology."

In Q3 2021, Ryvu participated in the following investor conferences:

Morgan Stanley 19th Annual Global Healthcare Conference (September 9 – 15), where Ryvu’s Chief Business Officer, Vatnak Vat-Ho participated in a fireside chat as well as hosted investor meetings during the conference. 
H.C. Wainwright 23rd Annual Global Investment Conference (September 13 -15), where Ryvu presented during the event as well as hosted investor meetings.
Ryvu 2021 Third Quarter, Financial Results

In the nine months of 2021, the Company reported PLN 19.6 million (USD 5.1 million) of revenues. Over 90% of this number were grants (PLN 18.2 million or USD 4.8 million) and the remainder consisted of income from partnering (PLN 0.5 million or USD 0.1 million), other revenues (PLN 0.5 million or USD 0.1 million) and other operating revenues in total PLN 0.4 million (USD 0.1 million).

Operating costs, excluding the non-cash expense of the Incentive Program (PLN 15.0 million or USD 3.9 million), in the audited period amounted to PLN 66.2 million (USD 17.4 million), and related primarily to research and development expenditures, while the operational loss without the Incentive Program was PLN 46.6 million (USD 12.2 million) compared to PLN 24.2 million (USD 6.1 million) reported in the corresponding period in 2020. Net loss without the Incentive Program for the nine months of 2021 amounted to PLN 45.6 million (USD 12.0 million) and the reported loss for the corresponding period of 2020 amounted to PLN 20.7 million (USD 5.3 million).

On October 31, 2021, Ryvu Therapeutics held PLN 84.9 million (USD 21.3 million) in cash, cash equivalents, and short-term investments.

On November 10, 2021 Amgen (NASDAQ:AMGN) reported that it will present at the 2021 annual Cowen IO Summit at 2:15 p.m. ET on Monday, Nov. 15, 2021 (Press release, Amgen, NOV 10, 2021, View Source [SID1234595154]). David M. Reese, M.D., executive vice president of Research and Development at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On November 10, 2021 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for common inflammatory conditions, reported results for the three- and nine-month periods ended September 30, 2021 and provided a corporate overview and business update (Press release, Ampio, NOV 10, 2021, View Source [SID1234595153]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Ms. Holli Cherevka, President and Chief Operating Officer, commented, "This quarter marked an exciting period of growth for drug development in the Ampion platform therapy, both in clinical and preclinical development.

We have locked the osteoarthritis Phase 3 pivotal trial database, and are currently analyzing the data, which may provide a significant treatment option for an unmet medical need in severely disabled patients.

We have commenced the enrollment and treatment of COVID-19 patients in India for the Phase 2 AP-019 study utilizing inhaled Ampion therapy compared to control.

Furthermore, we continue to investigate Ampion’s potential in new indications within the preclinical space, most recently publishing data supportive of application in acute kidney injury, and in the autoimmune space relating to lupus nephritis. This early data suggests we may still be just scratching the surface of Ampion’s potential."

Ms. Holli Cherevka, President and Chief Operating Officer, Howard Levy, M.B.B.Ch., Ph.D., M.M.M., Chief Medical Officer, David Bar-Or, MD, Director and Founder, and Mr. Daniel Stokely, Chief Financial Officer will be hosting a Conference Call for the Investment Community this afternoon beginning at 4:30 PM ET (see details below).

The key areas of focus during the call will be clinical and preclinical updates, as well as the financial results for the three and nine-month period ended September 30, 2021.

SEPTEMBER 30, 2021 FINANCIAL RESULTS

Cash and cash equivalents totaled $17.1 million as of September 30, 2021, compared to $17.3 million on December 31, 2020. The decrease of $0.2 million, or 1%, is primarily attributable to cash required to fund the operating activities of $10.4 million; partially offset by net proceeds received from the utilization of the at-the-market equity offering program and stock option / warrant exercises of $10.0 million and $0.2 million, respectively.

Research and Development Expenses: R&D expenses for the three months ended September 30, 2021 increased by $0.9 million, or 57%, from R&D expenses for the three months ended September 30, 2020. The increase was primarily attributable to costs associated with the continuation of the Phase I / II COVID studies and outsourced CRO efforts focused on finalizing the validation and quality review of the AP-013 study database.

R&D expenses for the nine months ended September 30, 2021 increased by $0.1 million, or 2%, from R&D expenses for the nine months ended September 30, 2020. The net increase was primarily attributable to an overall increase in pre-clinical research and production of clinical trial product totaling $ 0.8 million. These increases were partially offset by a decrease in clinical trial and sponsored research expenses during the current period of $0.5 million, attributable to the pause of the AP-013 study in April 2020, which was partially offset by the incremental costs associated with the validation and quality review of AP-013 database and incremental costs associated with the Phase I / II COVID-19 studies conducted during the current period.

General and Administrative Expenses: G&A expenses for the three months ended September 30, 2021, decreased by approximately $0.4 million, or 24%, from G&A expenses for the three months ended September 30, 2020. G&A expenses for the nine months ended September 30, 2021, decreased by approximately $0.7 million, or 15%, from G&A expenses for the nine months ended September 30, 2020. The decrease for both periods was primarily attributable to a decrease in litigation-related legal costs and commercial insurance costs.

The total shares of common stock outstanding were 200,458,263 on September 30, 2021, compared to 193,378,996 on December 31, 2020.

Financial Guidance

Based on its current projection and expected access to equity financing, Ampio expects to have cash and cash equivalents along with access to external sources of liquidity sufficient to fund its business operations through the first quarter of 2023.

Conference Call & Webcast:

In order to submit questions, participants must have internet connectivity, as questions will only be addressed via the webcast. The conference call line will be in listen only mode.

The conference call and webcast can also be accessed from the Investor Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.

On November 10, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the company will present at the Piper Sandler 33rd Annual Healthcare Conference, taking place virtually on November 29, 2021 (Press release, Sapience Therapeutics, NOV 10, 2021, View Source [SID1234595152]).

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Members of Sapience’s management team will present a company overview and will also participate in one-on-one meetings with life science investors during the event.