On March 13, 2020 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported fourth quarter and year-end 2019 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, MAR 13, 2020, View Source [SID1234555537]).

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Recent Highlights

Completed meeting with the U.S. Food & Drug Administration (FDA) to finalize the Phase 3 cytisinicline clinical development program

Presented new findings from the Phase 2b ORCA-1 trial evaluating cytisinicline in U.S. smokers at the Society for Research on Nicotine & Tobacco (SRNT) Annual Conference in March 2020

Established agreement with the FreeMind Group to assist in securing non-dilutive funding to evaluate cytisinicline in vapers and e-cigarette users

Closed underwritten public offering for gross proceeds of $13.8 million, before underwriting discounts and commissions and offering expenses

"With over 34 million smokers and nearly 11 million vape and e-cigarette users in the United States alone, the nicotine addiction epidemic continues to be a major public health crisis that Achieve is exclusively focused on addressing through the development of cytisinicline," commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. "Our key priorities in the coming months are to initiate the ORCA-2 Phase 3 clinical trial in smokers and secure non-dilutive financing to evaluate cytisinicline specifically in the growing population of vape users."

Completed FDA Meeting

In the fourth quarter of 2019, Achieve received feedback on the Phase 3 clinical trial protocols and the cytisinicline clinical development program. Specifically, the FDA agreed with the overall Phase 3 study designs that anticipate utilizing the simplified cytisinicline dosing schedule of 3.0 mg administered three times daily and the duration of 6 and 12 weeks of treatment. Additionally, the FDA agreed that no further escalation in cytisinicline dosing beyond the 30.0 mg dose was necessary for defining a maximum tolerated dose, which is required for the New Drug Application.

Additional ORCA-1 Results at SRNT Annual Conference

An oral presentation featuring new ORCA-1 Phase 2b trial analyses was presented at the SRNT Annual Meeting in March 2020. In addition to previously reported data indicating a statistically significant improvement in quit rates, new analyses demonstrate cytisinicline biochemical efficacy via measurement of serum cotinine as well as the previous carbon monoxide efficacy. Additionally, further analyses confirm that cytisinicline benefit was observed across all clinical sites, baseline characteristics, and attributes. Thus, regardless of trial site location, patient demographics, smoking history, or prior treatments, all subjects treated with cytisinicline showed similar smoking cessation benefit.

Agreement with the FreeMind Group to secure non-dilutive financing for vaping trials

Achieve retained the FreeMind Group, an international consulting firm dedicated to assisting life science organizations secure non-dilutive funding. Achieve and FreeMind will conduct a strategic assessment of potential non-dilutive funding opportunities from various public and private sources, followed by anticipated grant production and submission, to further the clinical development of cytisinicline in vaping or e-cigarette cessation.

Closed underwritten public offering for gross proceeds of $13.8 million

In December 2019, Achieve announced the closing of an underwritten public offering that raised total gross proceeds of $13.8 million, which includes the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses.

Financial Results

As of December 31, 2019, the company’s cash, cash equivalents, and restricted cash was $16.7 million. Total operating expenses for the fourth quarter and year ended December 31, 2019 were $3.2 million and $16.5 million, respectively. Total net loss for the fourth quarter and year ended December 31, 2019 was $3.2 million and $16.4 million, respectively.

As of March 13, 2020 Achieve had 31,352,764 shares outstanding.

Conference Call Details

Achieve will host a conference call at 8:30 a.m. Eastern time today, Friday, March 13, 2020. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6628874. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On March 13, 2020 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, reported financial results for the year ended December 31, 2019, and provided a corporate update (Press release, Lipocine, MAR 13, 2020, View Source [SID1234555536]).

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Fourth Quarter and Recent Corporate Highlights

·Resubmitted the New Drug Application ("NDA") in February 2020 for TLANDO, the Company’s oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
oThe NDA resubmission was made following a Post Action Meeting with the U.S. Food and Drug Administration ("FDA") to discuss a potential path forward for TLANDO. The NDA incorporates the reanalysis of existing data based on written feedback from the FDA to address the deficiency from the Complete Response Letter ("CRL") received from the FDA in November 2019.
oThe FDA has assigned a Prescription Drug User Fee Act ("PDUFA") goal date of August 28, 2020.
· Continued to actively enroll in the ongoing LPCN 1144 LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study, a paired-biopsy study in confirmed pre-cirrhotic non-alcoholic steatohepatitis ("NASH") patients.
oTop-line liver fat reduction data, as measured by MRI-PDFF at 12 weeks, are expected in the second half of 2020, followed by 36-week biopsy data which are expected by the first half of 2021.
·Raised $6.0 million in gross proceeds in a registered direct offering of common stock and warrants in February 2020.
·Raised $6.0 million in gross process in a public offering of common stock and warrants in November 2019.

"We are pleased that the FDA has assigned a new PDUFA date for TLANDO and are committed to working with the Agency towards the goal of achieving approval of TLANDO," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "Based on the recent Post Action Meeting and subsequent written feedback, the FDA has indicated our approach to addressing the deficiency from the most recent CRL appears to be a reasonable path forward. In parallel, we continue to develop LPCN 1144 for the treatment of NASH and look forward to announcing top line liver fat data from the ongoing LiFT clinical study in the second half of 2020."

Year Ended December 31, 2019 Financial Results

Lipocine reported a net loss of $13.0 million, or ($0.50) per diluted share, for the year ended December 31, 2019, compared with a net loss of $11.7 million, or ($0.55) per diluted share, for the year ended December 31, 2018.

Research and development expenses were $7.5 million for the year ended December 31, 2019, compared with $6.5 million for the year ended December 31, 2018. The increase in research and development expenses during the year ended December 31, 2019 was primarily due to increases in contract research organization and outside consulting and manufacturing costs for LPCN 1144 and an increase in costs for TLANDO XR (LPCN 1111), offset by a decrease in costs incurred in conjunction with TLANDO with the completion of the ABPM study and the filing of the NDA in the first half of 2019, a decrease in contract manufacturing costs for LPCN 1107 and a decrease in personnel expense.

General and administrative expenses were $5.6 million for the year ended December 31, 2019, compared with $5.3 million for the year ended December 31, 2018. The increase in general and administrative expenses was primarily due to increases in legal and corporate insurance costs offset by a decrease in personnel costs.

As of December 31, 2019, the Company had $14.1 million of unrestricted cash, cash equivalents and marketable investment securities compared to $15.3 million at December 31, 2018. Additionally, as of December 31, 2019 and December 31, 2018 the Company had $5.0 million of restricted cash, which is required to be maintained as cash collateral under the SVB Loan and Security Agreement until TLANDO is approved by the FDA. In February 2020, the Company raised an additional $6.0 million in gross proceeds from a registered direct offering of common stock and warrants.

On March 13, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the year ended December 31, 2019 and provided a business update (Press release, Sellas Life Sciences, MAR 13, 2020, View Source [SID1234555533]).

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"Our clinical and corporate progress in 2019 has laid the foundation for a busy and exciting 2020. We are progressing our clinical development program for galinpepimut-S (GPS), including our Phase 3 REGAL study in acute myeloid leukemia (AML), our Phase 1/2 basket study in combination with pembrolizumab (KEYTRUDA), and our Phase 1 trial in combination with nivolumab (Opdivo) in malignant pleural mesothelioma (MPM). The positive follow-up data of the Phase 2a AML CR2 study announced last month further support our Phase 3 REGAL study design," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Additionally, we have received and incorporated feedback from the U.S. Food and Drug Administration (FDA) on the design and plan for a Phase 3 registration-enabling study of nelipepimut-S (NPS) in patients with triple negative breast cancer (TNBC). Coupled with the Phase 2b data for NPS in combination with pembrolizumab in TNBC patients that were recently published in Clinical Cancer Research, this supports our business development efforts to pursue out-licensing opportunities for NPS’ clinical development."

Recent Pipeline Highlights

Galinpepimut-S (GPS) Program

In February 2020, SELLAS announced positive follow-up data from its Phase 1/2 study of GPS in patients with AML in second complete remission (CR2). The final data show a median overall survival (OS) of 21.0 months, at a median follow-up of 30.8 months, in patients receiving GPS compared to 5.4 months in patients treated with best standard care (p-value < 0.02). GPS therapy continued to be well-tolerated throughout the study.
In February 2020, SELLAS announced the enrollment of the first patient in an investigator-sponsored clinical trial of GPS in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab (Opdivo), in patients with MPM.
In January 2020, SELLAS announced that it has commenced patient screening for its pivotal Phase 3 REGAL study of GPS in patients with AML in CR2.

Nelipepimut-S (NPS) Program

Today, SELLAS is announcing that final results from the efficacy and safety data analysis of the Phase 2b independent investigator-sponsored clinical trial of the combination of trastuzumab (Herceptin) +/- NPS targeting HER2 low-expressing breast cancer patient cohorts, including TNBC patients, were recently published in the peer reviewed journal, Clinical Cancer Research. With regard to the TNBC patient cohort, the data analysis shows:
º Disease-free survival (DFS) landmark rate at 24 months for patients treated with NPS plus trastuzumab (n=53) was 92.6% compared to 70.2% for those treated with trastuzumab alone (n=44), a clinically and statistically significant improvement.
º There was a statistically significant reduction of 71.9% (p=0.01) in the frequency of clinically detected recurrences in patients treated with the combination (NPS plus trastuzumab) versus trastuzumab alone.
º The combination was generally well-tolerated and there were no clinicopathologic differences between the study groups.
In February 2020, SELLAS announced it finalized the design and plan for a Phase 3 registration-enabling study of NPS in combination with trastuzumab for the treatment of patients with TNBC in the adjuvant setting after standard treatment, following feedback from a Type C review with the FDA. SELLAS is actively pursuing out-licensing opportunities to fund and conduct the future clinical development of NPS.
Recent Corporate Highlights

In February 2020, SELLAS announced the appointment of Dragan Cicic, MD, as Senior Vice President, Clinical Development.
In January 2020, SELLAS entered into a securities purchase agreement with institutional investors to purchase approximately $6.5 million of its common shares (or pre-funded warrants to purchase common shares in lieu thereof) in a registered direct offering priced at-the-market and warrants to purchase common shares in a concurrent private placement.
Year End 2019 Financial Results

Cash Position: As of December 31, 2019, cash and cash equivalents were $7.3 million, compared to $5.3 million as of December 31, 2018. Net cash used in operating activities was $17.6 million for the year ended December 31, 2019, compared to $30.4 million for the year ended December 31, 2018. Net cash provided by financing activities was $19.6 million for the year ended December 31, 2019, primarily attributable to $16.0 million in net proceeds from the sale of equity securities and $3.6 million in net proceeds from the exercise of warrants to acquire shares of common stock. For the year ended December 31, 2018, net cash provided by financing activities was $23.1 million, primarily attributable to $31.2 million in net proceeds from the sale of equity securities, partially offset by $7.6 million in principal payments on previously outstanding debt and $0.5 million in cash dividends paid to the holders of previously outstanding preferred stock.

R&D Expenses: Research and development expenses were $7.3 million for the year ended December 31, 2019, as compared to $8.8 million for the year ended December 31, 2018. The $1.5 million decrease was primarily due to a $1.0 million decrease in personnel related expenses due to decreased headcount, a $0.6 million decrease in licensing fees primarily due to a clinical milestone for GPS recognized in 2018, a $0.3 million decrease in clinical expenses due to the completion of the Phase 2b trial of NPS in combination with trastuzumab in 2018 and a $0.2 million decrease in other research and development expenses. These decreases were partially offset by a $0.6 million increase in manufacturing related expenses for GPS.

G&A Expenses: General and administrative expenses were $9.9 million for the year ended December 31, 2019, as compared to $12.8 million for the year ended December 31, 2018. The $2.9 million decrease was primarily driven by a $0.8 million decrease in outside services and public company costs, a $0.7 million decrease in legal fees, a $0.7 million decrease in personnel related expenses due to reduced headcount, a $0.4 million decrease in rebates and returns related to former commercial products, a $0.2 million decrease in accounting fees, and a $0.3 million decrease in other general and administrative expenses. These decreases during 2019 reflect the Company’s efforts to limit expenses in order to preserve capital. These decreases were partially offset by a $0.2 million increase in insurance premiums.

Net Loss: Net loss for the year ended December 31, 2019 was $19.3 million and loss attributable to common stockholders was $28.0 million, or a basic and diluted loss per share to common stockholders of $10.92, as compared to a net loss of $27.7 million and loss attributable to common stockholders of $41.3 million for the year ended December 31, 2018, or a basic and diluted loss per share to common stockholders of $157.72. Net loss and loss attributable to common stockholders for the year ended December 31, 2019 includes a $2.8 million one-time non-cash impairment charge of in-process research and development associated with the abandonment of future development of GALE-301 and GALE-302, cancer immunotherapies that target the E39 peptide derived from the folate binding protein, as they are outside of the Company’s core focus of the development of GPS. Net loss and loss attributable to common stockholders for the year ended December 31, 2018 includes a $9.6 million one-time non-cash impairment charge of in-process research and development associated with the termination of a license agreement for anagrelide CR formulation (GALE-401).

Keytruda and Herceptin are registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, and Genentech, Inc., respectively, and are not trademarks of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.

On March 13, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported the signing of a Product Supply Agreement with the Idaho State University Idaho Accelerator Center (IAC) for the production and commercial supply of copper-67 (Cu-67) (Press release, Clarity Pharmaceuticals, MAR 13, 2020, View Source [SID1234555497]).

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Under the new agreement, IAC will supply Clarity with Cu-67 for planned clinical development, including the SARTATETM trial in children with neuroblastoma and SAR-bisPSMA trial in prostate cancer patients in the United States. IAC has been Clarity’s long-term partner, providing a reliable supply of high purity and high specific activity Cu-67 for some years. IAC’s proven experience in the production and supply of Cu-67 has already allowed Clarity to initiate and complete therapeutic studies in a range of cancer types both in the United States and in Australia.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to bolster our relationship with IAC to further progress our pipeline of theranostic agents in the fight against cancer. IAC’s electron accelerator capability enables Clarity to eliminate the reliance on supply from the limited number of aging nuclear reactors which currently produce therapeutic radionuclides such as lutetium-177. This gives Clarity the opportunity to move swiftly through clinical trials with its three main products, SARTATETM, SAR-bisPSMA and SAR-BBN in such indications as neuroblastoma, neuroendocrine tumours, prostate cancer, breast cancer and brain cancers.

"We are pleased to have signed the Product Supply Agreement with Clarity and are looking forward to continuing our supply of this copper isotope using our increased capacity and our world leading e-linac process to produce a high purity product at very high specific activity," said Jon Stoner, director of the IAC. "Clarity’s proprietary chelator technology along with our patent protected commercially produced Cu-67 combine to showcase a future market leading medical isotope."

Dr Taylor further commented, "Clarity is a clinical stage radiopharmaceutical company that is uniquely placed to control its full supply chain within the United States. With IAC further planning on additional facilities to support the development of Cu-67 production and with Clarity having recently signed a Letter of Intent with NorthStar Medical to supply and industrialise the production of this therapeutic isotope, we are well underway towards building stable and reliable commercial-scale supply of Cu-67 for our late-phase trials and market entry of our products in a number of large cancer indications".

About Copper-67 (Cu-67)
Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope which is attractive for medical purposes due to its ability to carry sufficient radiation energy to cause cell death in targeted cells while having a sufficiently short half-life to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes across a wide range of adult and childhood cancers. Potential radiotherapeutic targets include prostate cancer, breast cancer, neuroendocrine tumours (NETs), neuroblastoma, glioma, lymphoma, ovarian cancer and bladder cancers. In order to develop safe and effective targeted therapies, a chelator, which strongly binds Cu-67 to the targeting agent, is required. Clarity Pharmaceuticals has successfully developed a highly specific and highly stable chelator for copper isotopes and is now progressing a range of radiopharmaceuticals based on its proprietary MeCOSar chelator. The IAC has developed a proprietary process for production of high purity and high specific activity Cu-67 to meet demand for clinical research and treatment.

On March 12, 2020 Tyligand Bioscience, Ltd., a leader in small molecule drug discovery and development, and Context Therapeutics LLC, a clinical stage biopharmaceutical company focused on hormone driven cancers, reported the signing of collaboration agreements for the development, manufacturing, registration and future commercialization of onapristone extended release (ER) (Press release, Tyligand Bioscience, MAR 12, 2020, View Source [SID1234644992]).

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Onapristone ER is currently being evaluated in patients with progesterone receptor positive (PR+) ovarian and endometrial cancers in the ongoing Phase 2 ONWARD 220 clinical trial. Initiation of additional Phase 2 clinical trials in ER+, PR+, HER2- breast cancer and endometrial cancers are planned for mid-2020.

Under the terms of the agreements, Tyligand will be solely responsible for the design and optimization of a novel manufacturing process for onapristone ER to meet Context’s development and future commercialization needs, and standards for quality, safety and cost. Upon completion of specific performance-based milestones, Tyligand will be granted the exclusive right and will be solely responsible for the development and commercialization of onapristone ER in China, Hong Kong and Macau (the "Territory"), and Context will be eligible to receive royalties on net sales of onapristone ER in the Territory. Context will retain rest of world rights to commercialize onapristone ER.

"We are thrilled to partner with Tyligand as we accelerate onapristone ER’s Phase 2 evaluation and prepare for Phase 3," said Martin Lehr, CEO of Context. "Tyligand is renowned for its expertise in process development and has strong networks with manufacturing and clinical capabilities in China and the U.S. Partnering with Tyligand will enable Context to optimize and efficiently scale our manufacturing and clinical capacity to support the evaluation and future commercialization of onapristone ER, our experimental oral therapy, to address the unmet need in treating patients with PR+ cancers."

"Even with the major advances in cancer therapies in recent years, treatment options for patients with hormone driven cancers remain limited," said Tony Zhang, CEO of Tyligand."Onapristone ER has the potential to be the first-in-class therapeutic agent specifically targeting progesterone receptors and the best-in-class treatment option for breast, endometrial and ovarian cancers. We are proud to partner with Context to develop onapristone ER and make this innovative medicine ultimately more accessible for patients around the world."