On November 9, 2021 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 third quarter 2021 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, NOV 9, 2021, View Source [SID1234594990]).

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Recent Highlights

Provided an update on the ORCA-2 Phase 3 clinical trial, including announcing that all subjects have completed the treatment portion of the study and are in follow-up, and that topline data is expected in the first half of 2022
Discussed ongoing planning activities for ORCA-3, the second Phase 3 clinical trial supporting cytisinicline regulatory submission in the United States, which Achieve anticipates could launch by early 2022
Announced FDA acceptance of IND application for the evaluation of cytisinicline in nicotine e-cigarette cessation
Issued two new patents from the United States Patent and Trademark Office covering the novel 3.0 mg TID cytisinicline dosing regimen
Presented cytisinicline data at the Society for Research on Nicotine & Tobacco Europe (SRNT-E) annual meeting
Announced expansion of cytisinicline clinical operations team
"It has been another successful quarter as we continue to focus on meeting our key development milestones, specifically, completing the Phase 3 ORCA-2 trial, and preparing for the initiation of two new cytisinicline trials," commented John Bencich, Chief Executive Office of Achieve. "We are looking forward to an exciting year ahead with the expected ORCA-2 Phase 3 data results, the start of our second Phase 3 study in cigarette smoking cessation and launch of the grant-funded ORCA-V1 trial in e-cigarette cessation."

Ongoing ORCA-2 Phase 3 Clinical Trial
Achieve provided an update on the cytisinicline development program in adult cigarette smokers in the United States. The ORCA-2 Phase 3 trial completed enrollment of 810 subjects. To date, all subjects have completed study treatment and are currently in follow-up. The last subject is expected to complete their final visit by the end of 2021, with topline data expected to be announced in the first half of 2022.

Planned ORCA-3 Phase 3 Clinical Trial
Achieve reviewed ORCA-3 planning activities and announced that it has completed selection of a Contract Research Organization (CRO), finalized cytisinicline packaging and drug supply, and is currently undergoing clinical trial site selection. The trial is expected to initiate enrollment of approximately 750 adult cigarette smokers by early 2022.

FDA Acceptance of IND for Study of Cytisinicline in e-Cigarette Cessation
Achieve announced that the U.S. Food and Drug Administration (FDA) has completed their review and accepted an Investigational New Drug (IND) application to investigate cytisinicline as a cessation treatment for nicotine e-cigarette users. The Phase 2 ORCA-V1 study will enroll approximately 150 adult nicotine e-cigarette users in the United States and is expected to initiate in the second quarter of 2022. Grant funding to support the trial has been awarded in two phases from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH). Completion of required milestones for the first phase of grant funding included the submission of the IND and clearance to proceed with the clinical trial by FDA.

Patents Issued for 3.0 mg TID Dosing Regimen
The U.S. Patent and Trademark Office issued U.S. Patent No. 11,083,715 and U.S. Patent No. 11,083,716 covering the novel 3.0 mg TID cytisinicline dosing regimen. Not including any patent term extensions to which Achieve may be entitled, the newly issued patents will expire in the third quarter of 2040. Upon approval of cytisinicline by the FDA, Achieve anticipates these patents would be included in the FDA’s Orange Book, which lists approved drugs and related patent and exclusivity information.

Cytisinicline Data Presented at SRNT-E Annual Meeting
Two cytisinicline data presentations were included in the SRNT-E annual meeting, held in September 2021. An analysis from the ORCA-1 trial found that subjects who previously failed to quit smoking with Chantix (varenicline) experienced a Week 4 abstinence rate of 51.3% upon treatment with cytisinicline using the three times daily (TID) regimen, compared with 15.8% with placebo (p= 0.009). An additional analysis, also from the ORCA-1 trial, found that smokers treated in the study with cytisinicline showed an earlier onset of sustained abstinence compared with placebo. Smokers who received the cytisinicline 3 mg TID had the shortest time to sustained smoking abstinence with a median of only 7 days of treatment compared to 18 days for placebo.

Expanded Clinical Operations Team
Achieve announced the expansion of its clinical operations team to include a Senior Director of Biometrics, Senior Manager of Clinical Trials, and Director of Clinical Operations, to support efforts with the ongoing and planned cytisinicline development program.

Financial Results
As of September 30, 2021, Achieve’s cash equivalents, and restricted cash was $33.4 million. Total operating expenses for the three and nine months ended September 30, 2021 were $6.7 million and $26.0 million, respectively. Total net loss for the three and nine months ended September 30, 2021 was $6.7 million and $26.0 million, respectively.

As of November 9, 2021, Achieve had 9,453,542 shares outstanding.

Conference Call Details
Achieve will host a conference call at 4:30pm Eastern time today, Tuesday, November 9, 2021. 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 7997636. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On November 9, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported its financial results for the third quarter ended September 30, 2021 (Press release, Calithera Biosciences, NOV 9, 2021, View Source [SID1234594989]).

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"The last month has been one of significant change for Calithera, following the acquisition of two clinical-stage investigational therapies, sapanisertib and mivavotinib, and the presentation of interim data from our cystic fibrosis program for CB-280 that supports our approach to the treatment of CF via this mechanism," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "During this quarter, we also announced the disappointing news of the discontinuation of the telaglenastat program based on an interim analysis of the KEAPSAKE trial. Finally, we announced the promotion of Emil Kuriakose to chief medical officer and the strengthening of our board of directors with the addition of Calithera’s former chief medical officer, Keith Orford.

"We move into the end of 2021 with a keen focus on biomarker-defined cancer patient populations and remain committed to our pursuit of developing medicines to improve outcomes for people with diseases of high unmet need. Our near-term clinical development plans include leveraging our clinical and biomarker expertise in the KEAP1/NRF2 pathway by developing our mTORC1/2 inhibitor sapanisertib in squamous non-small cell lung cancer, and advancing the development of our SYK inhibitor mivavotinib in specific biomarker-defined populations of diffuse large B-cell lymphoma. By focusing on well-characterized genetic vulnerabilities with molecules that have already shown single-agent activity, we will be able to generate phase 2 data with targeted, efficient study designs over the next 12 to 18 months."

Third Quarter 2021 and Recent Highlights

Acquired clinical stage dual mTORC 1/2 inhibitor sapanisertib and SYK inhibitor mivavotinib from Takeda Pharmaceuticals. The acquisition significantly strengthens Calithera’s precision oncology pipeline with addition of two drugs that have both demonstrated single-agent activity in the clinic, with the greatest potential in biomarker-defined cancer patient populations. Calithera plans to initiate a phase 2 study to begin in the first quarter of 2022 that will strengthen the existing data on sapanisertib as an active single-agent drug in patients with squamous non-small cell lung cancer (NSCLC) harboring a NRF2 or KEAP1 mutation. In addition, Calithera will initiate a phase 2 study of mivavotinib in the first quarter of 2022 for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) with and without mutations in MyD88 and CD79. Data from these studies generated over the next 12 to 18 months could position the company to initiate registrational studies for both molecules.

Presented interim data from the Phase 1b clinical trial of CB-280 in patients with cystic fibrosis (CF) at North American Cystic Fibrosis Conference. Data showed CB-280 was well-tolerated, had linear PK, and demonstrated robust dose-related PD effects. Encouraging trends were seen in disease biomarkers, including increased fractional exhaled nitric oxide (FeNO) and decreased sweat chloride. A pooled analysis of treatment vs. placebo showed a positive trend in forced expiratory volume in one second (FEV1) compared to placebo. Dose escalation is ongoing with cohort 4 (300mg BID) and on track to complete enrollment by the end of the year, with the option for an additional dose cohort to enroll in 2022 if warranted.

Announced discontinuation of phase 2 telaglenastat KEAPSAKE clinical trial in patients with NSCLC with genetic mutations in KEAP1/NRF2. Interim analysis from 40 patients demonstrated lack of clinical benefit among patients treated with telaglenastat. No differences in safety profile were seen between the two arms.

Promoted Emil Kuriakose, MD, from vice president and head of clinical development to chief medical officer. Dr. Kuriakose succeeds Keith Orford, MD, PhD who has resigned from his position and joined the Calithera Board of Directors.

Preclinical focus on synthetic lethality targets. In addition to the company’s clinical programs, Calithera continues to leverage its discovery engine to build a robust preclinical pipeline of undisclosed synthetic lethality targets with a focus on paralog genes. These will be announced as Calithera advances preclinical development.

Selected Third Quarter 2021 Financial Results

Cash, cash equivalents and investments totaled $84.5 million at September 30, 2021. Calithera expects its cash, cash equivalents and investments will be sufficient to meet its current operating plan into 2023.

Revenue was $6.8 million for the three months ended September 30, 2021, and represents the milestone payment received in September 2021 under Calithera’s Incyte Collaboration Agreement.

Research and development expenses for the third quarter 2021 were $11.6 million, compared to $18.2 million in the same period prior year. The decrease of $6.6 million was primarily due to decreases in the telaglenastat and INCB001158 programs, partially offset by investments in early-stage research.

General and administrative expenses for the third quarter 2021 were $6.3 million, compared to $4.7 million in the same period prior year. The increase of $1.6 million was primarily due to increased legal expenses.

Net loss for the three months ended September 30, 2021, was $11.2 million.

Conference Call Information

Calithera will host an update conference call today, Tuesday, November 9, at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and referring to conference ID 3797324. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On November 9, 2021 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the third quarter ended September 30, 2021, and provided an update on the progress of its clinical programs (Press release, vTv Therapeutics, NOV 9, 2021, View Source [SID1234594988]).

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"We plan to refocus vTv’s strategy on TTP399. TTP399 is unique and the most important product in our portfolio with strong equity value potential to our shareholders", said Deepa Prasad, president and CEO, vTv Therapeutics. "Biotech is about innovation and meeting the unmet medical needs for patients. TTP399 does exactly this in seeking to solve the unmet need for type 1 diabetic patients experiencing hypoglycemic episodes. We are excited the FDA supports our effort by granting us Breakthrough Therapy Designation. Hypoglycemia is the most common acute complication for type 1 diabetes with onset occurring quickly and often without warning. We believe TTP399 can address this critical unmet need for type 1 diabetic patients worldwide."

Recent Achievements and Outlook

Corporate

Leadership. On October 19, 2021, Deepa Prasad was appointed to the role of President and CEO, and joined the board of directors. Deepa is a recognized healthcare leader with more than 20 years of experience across startup funding, operations, investment banking, and healthcare policy. Most recently, Deepa led investments in innovative life science companies as a managing director at West River Group.

Strategic Focus. We plan to implement a strategy to focus our efforts on the continued development of TTP399 as a potential treatment for patients with type 1 diabetes ("T1D") and TTP273 as a potential treatment for patients with cystic fibrosis related diabetes, as well as continuing to support our currently partnered programs. Given the strategic focus on these programs, we plan to pause our development activities in the United States on HPP737 while we evaluate strategic options for it. As part of this planned strategic focus, we are also evaluating cost reductions which may include reductions in our workforce.

Balance Sheet. The Company strengthened its balance sheet during the quarter through utilization of the at-the-market equity program with Cantor Fitzgerald, ending the quarter with $19.6 million of cash, cash equivalents and marketable securities.
Type 1 Diabetes

Mechanistic Study of Ketoacidosis with TTP399. In October 2021, the Company announced positive results from the mechanistic study of TTP399 in people with type 1 diabetes. Patients with type 1 diabetes taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating that treatment with TTP399 presents no increased risk of ketoacidosis. In addition, patients taking TTP399 had improved fasting plasma glucose levels and experienced fewer hypoglycemic events relative to those taking placebo, consistent and supportive of the previously announced phase 2 SimpliciT1 Study results.

Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with type 1 diabetes and is engaged with the FDA on the optimal clinical trial designs for these studies. The Company expects to begin these pivotal studies in the first half of 2022.
Third Quarter 2021 Financial Results

Cash Position: The Company’s cash position as of September 30, 2021, was $19.6 million compared to $10.8 million as of June 30, 2021.

Revenue: Revenue for the third quarter of 2021 was $3.0 million, attributable to the satisfaction of milestones under the license agreements with Newsoara Biopharma Co., Ltd. and Reneo Pharmaceuticals, Inc. Revenue for the second quarter of 2021 was an insignificant amount.

R&D Expenses: Research and development expenses were $2.4 million in each of the three months ended September 30, 2021 and June 30, 2021, respectively.

G&A Expenses: General and administrative expenses were consistent between periods at $2.2 million for each of the three months ended September 30, 2021 and June 30, 2021.

Other Income/(Expense): Other expense for the three months ended September 30, 2021 was $0.2 million and was attributable to the gains related to a reduction in fair value of the warrants to purchase shares of our own stock issued to a related party (the "Related Party Warrants") offset by losses driven by the decrease in the fair value of our investment in Reneo Pharmaceuticals, Inc. (the "Reneo Investment"). Other income for the three months ended June 30, 2021 of $3.8 million was driven by changes in value of the Reneo Investment and gains related to the reduction in fair value of the Related Party Warrants.

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $1.5 million for the third quarter of 2021 compared to net loss before non-controlling interest of $0.8 million for the second quarter of 2021.

Net Loss Per Share: Diluted net loss per share was ($0.02) for the three months ended September 30, 2021 compared to diluted net loss per share of ($0.01) for the three months ended June 30, 2021, based on weighted-average diluted shares of 61.1 million and 58.6 million for the three-month periods ended September 30, 2021 and June 30, 2021, respectively.

On November 9, 2021 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that management will be participating in the following investor conferences (Press release, Sangamo Therapeutics, NOV 9, 2021, View Source [SID1234594987]):

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Barclays Gene Editing & Gene Therapy Summit
Date: Monday, November 15th at 10:30 a.m. Eastern Time
Stifel 2021 Virtual Healthcare Conference
Date: Monday, November 15th at 3:20 p.m. Eastern Time
Jefferies London Healthcare Conference
Date: Tuesday, November 16th at 8:40 a.m. Eastern Time
For presentations and fireside chats that are webcast live, an access link will be available on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentations will also be available on the Sangamo Therapeutics website after the event.

On November 9, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology company, developing new precision medicine treatment options for cancer patients in indications with the greatest unmet medical need including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported that company management will present and participate in virtual 1×1 investor meetings at the Jefferies London Healthcare Conference and the Piper Sandler 33rd Annual Healthcare Conference, taking place November 16 – 19, 2021, and November 29 – December 2, 2021, respectively (Press release, Cardiff Oncology, NOV 9, 2021, View Source [SID1234594986]).

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Details on the presentations can be found below.

Jefferies London Healthcare Conference

Presentation Date:

Available on-demand beginning at 8:00 AM GMT (3:00 AM ET) on November 18, 2021

Piper Sandler 33rd Annual Healthcare Conference

Presentation Date:

Available on-demand beginning at 10:00 AM ET on November 22, 2021

Webcasts of the presentations will be available by visiting the "Events" section of the Cardiff Oncology website and will be archived for 30 days.