On August 12, 2021 Cardinal Health reported an agreement with TerraPower that will help advance the next generation of cancer treatment (Press release, Cardinal Health, AUG 12, 2021, View Source [SID1234591439]). Working together, the companies will develop and produce Actinium-225, which will be utilized in drug trials involving targeted alpha therapy for diseases such as breast, prostate, colon and neuroendocrine cancers, melanoma and lymphoma. Learn more in today’s press release

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On August 12, 2021 Kuraray reported that Business Results for the Second Quarter of the Fiscal Year Ending December 31, 2021(Press release, Kuraray, AUG 12, 2021, https://pdf.irpocket.com/C3405/GbYe/jzI0/lMPt.pdf [SID1234586368])

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(1) Consolidated Operating Results (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

(2) Consolidated Financial Position

3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2021 (January 1, 2021 to December 31, 2021)

1. Qualitative Information regarding Business Results

(1) Overview of Consolidated Business Results In the second quarter of fiscal 2021 (January 1, 2021–June 30, 2021), the world economy was still feeling the effects of the COVID-19 pandemic, and the outlook remained unclear; however, with the United States and China in the lead, some nations and regions began to make progress on recovery. However, soaring raw material and fuel prices, material supply shortages, and rising logistics costs are pushing down corporate profits. Consequently, consolidated operating results for the second quarter of fiscal 2021 are as follows: net sales rose ¥40,290 million, or 15.4%, compared with the previous fiscal year to ¥302,296 million; operating income increased ¥10,787 million, or 55.0%, to ¥30,398 million; ordinary income increased ¥10,858 million, or 61.6%, to ¥28,496 million; and net income attributable to owners of the parent increased ¥2,549 million, or 27.8%, to ¥11,710 million. The Group’s long-term vision for its 100th anniversary coming up in 2026, Kuraray Vision 2026, is to become a "Specialty Chemical Company, growing sustainably by incorporating new foundational platforms into its own technologies." We will continue striving to optimize our business portfolio by steadily taking specific measures based on the three basic policies of Kuraray Vision 2026: pursuing competitive superiority, expanding new business fields and enhancing comprehensive strength of the Kuraray Group. In fiscal 2021, we will focus on safe and stable operations amid the pandemic as well as thoroughly implement various measures decided on during the period of the previous medium-term management plan "PROUD 2020." At the same time, we will move ahead with formulating the next medium-term management plan, which is set to start in fiscal 2022.

(1) Sales of PVA resin increased as global demand began to recover, but production was affected by the cold wave that hit the southern United States in February 2021. Sales of optical-use poval film were brisk due to an increase in demand for LCD panels, especially large displays, from the second half of the previous fiscal year. The sales volume of PVB film rose on the back of a recovery in demand for both construction and automotive applications. Sales of water-soluble PVA film steadily expanded for use in unit dose detergent packets, including for laundry and dish detergents.

(2) The sales volume of EVAL ethylene vinyl alcohol copolymer (EVOH resin) increased as demand for gas tank applications recovered, but production was affected by the cold wave in the southern United States. Isoprene Sales in this segment increased 23.2% year on year to ¥30,462 million, and segment income rose 51.7% year on year to ¥3,210 million.Functional Materials Sales in this segment increased 9.4% year on year to ¥64,721 million, and segment income rose 188.6% year on year to ¥3,042 million.

(1) In the methacrylate business, sales of spatter-blocking barrier panels and displays increased. In addition, market conditions recovered.

(2) In the medical business, the dental materials business saw brisk sales, mainly in Europe and the United States, with contributions from the launch of new products.

(3) In the environmental solutions business, there were signs of a recovery for industrial applications, and sales of activated carbon remained steady. Fibers and Textiles Sales in this segment rose 5.9% year on year to ¥29,890 million while segment income increased 20.3% year on year to ¥1,992 million

On August 12, 2021 F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation bispecific immunotherapies to transform the lives of patients with cancer, reported second quarter 2021 financial results and provides a corporate update (Press release, F-star, AUG 12, 2021, View Source [SID1234586419]).

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The Company today announces an expanded clinical development strategy for FS118, F-star’s first-in-class bispecific antibody targeting LAG-3 and PD-L1, into checkpoint inhibitor naïve patients. This new study with FS118 is in biomarker enriched subsets of patients with non-small cell lung cancer (NSCLC) and diffuse large B-cell lymphoma (DLBCL). By moving into earlier lines of therapy, FS118 has the potential not only to delay, but also to prevent checkpoint resistance, which could provide an alternative treatment for patients who do not see a durable benefit from currently approved immunotherapies.

In addition to the expanded FS118 clinical strategy, F-star has three other ongoing clinical stage programs. These programs are combined with a strong balance sheet, having closed an underwritten public offering of stock and its "at the market" facility during Q2, which will enable the company to deliver multiple clinical data milestones. At the end of the second quarter the company had over $80 million in cash and cash equivalents. In the past quarter, F-star has also delivered on clinical and business development objectives, specifically the recent interim Phase 1 update on SB 11285 and the announcement of two major collaborations, a licensing agreement with AstraZeneca Plc for STING inhibitors and a supply agreement with MSD (Merck & Co., Inc., Kenilworth, NJ, USA) to evaluate the combination of FS120, F-star’s first-in-class dual-agonist, tetravalent, bispecific antibody targeting CD137 and OX40, with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy.

Eliot Forster, CEO of F-star Therapeutics, Inc., said, "I’m happy to share today the expansion of the FS118 clinical development program into checkpoint naïve patients. By targeting LAG-3, which was recently externally validated in the clinic as an important target, and PD-L1 simultaneously, we believe FS118 has the opportunity to improve patient outcomes over those seen with first generation immunotherapies. We also continue to focus on the checkpoint inhibitor refractory patient population in our ongoing FS118 proof-of-concept study in head and neck cancers. We are also pleased to have concluded two new collaborations, with AstraZeneca and MSD for STING antagonists and combining Keytruda with FS120, respectively.

"We believe that our strong balance sheet, expanded strategy for FS118, continuing and beneficial partnerships, along with our dedicated staff and investors, position F-star for a promising 2021 and beyond. We look forward to sharing data with you at upcoming medical conferences, including at ESMO (Free ESMO Whitepaper) next month."

SECOND QUARTER 2021 AND RECENT HIGHLIGHTS

FS118 development expansion plans following recent external clinical validation of LAG-3: Phase 3 data with LAG-3 at ASCO (Free ASCO Whitepaper) 2021, further supported F-star’s expansion of the FS118 clinical development plan into checkpoint naïve, biomarker enriched NSCLC and DLBCL patients. This study is anticipated to begin in the second half of 2021.

Strong financial position: In Q2 2021, the Company received $82.6 million in gross proceeds through the combination of an underwritten public offering of stock and use of its "at the market" facility.

FS222 Poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in 2021: In April, F-star presented a poster at AACR (Free AACR Whitepaper) 2021 entitled ‘FS222, a Tetravalent Bispecific Antibody Targeting CD137 and PD-L1, is Designed for Optimal CD137 Interactions Resulting in Potent T cell Activation Without Toxicity’. This poster and the associated data showcased the differentiation of FS222 from competitor molecules and highlighted the importance of ‘tuning’ for both the affinity and avidity of bispecific antibodies.

Combination of FS120 with KEYTRUDA: Last week, F-star announced a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Kenilworth, NJ, USA), to evaluate the combination of FS120, F-star’s first-in-class dual-agonist tetravalent bispecific antibody targeting CD137 and OX40, with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy.

SB 11285 Phase 1 interim update: In July, F-star provided an interim update on the safety, tolerability and pharmacokinetics of its intravenously administered novel STING agonist, alone and in combination with atezolizumab. SB 11285 appeared to be well tolerated both alone and in combination across all dose levels tested to-date, including five dose levels as monotherapy and three dose levels as a combination. The Part 1a/1b study database lock, as defined in the contingent value rights (CVR) agreement entered into in connection with the transaction with Spring Bank Pharmaceuticals, Inc., has been completed. Based on the positive emerging clinical data, further dose escalations are ongoing and a further clinical update is planned for 2022.

SB 11285 in Nature publication and composition of matter patent granted in the US: F-star published on its second-generation STING agonist, SB 11285, in the April 2021 issue of Nature Communications. The study, entitled ‘STING enhances cell death through regulation of reactive oxygen species and DNA damage’ demonstrated that systemic administration of a STING agonist in combination with radiation in a preclinical model enhances local control in Head and Neck Squamous Cell Carcinoma (HNSCC) and suggests that STING expression in the tumor is required for maximal therapeutic benefit. The US Patent Office granted a patent during the quarter with claims protecting the composition of matter of F-star’s SB 11285 molecule giving protection until 2037.

AstraZeneca licenses STING inhibitors: In July, F-star entered into an exclusive licensing agreement with AstraZeneca plc under which AstraZeneca received global rights to research, develop and commercialize next generation Stimulator of Interferon Genes (STING) inhibitor compounds. AstraZeneca was granted exclusive access to F-star’s novel preclinical STING inhibitors and will be responsible for all future research, development and commercialization of the STING inhibitor compounds. F-star retains rights to all STING agonists, currently in clinical development for patients with cancer. This agreement is subject to the second CVR with the former shareholders of Spring Bank Pharmaceuticals.

SECOND QUARTER 2021 FINANCIAL SUMMARY

Cash and cash equivalents as of June 30, 2021, were $81.6 million, compared to $18.5 million at December 31, 2020.

Research & Development (R&D) expenses were $8.4 million for the quarter ended June 30, 2021, compared to $2.1 million for the corresponding quarter in 2020. The $6.3 million increase was primarily related to manufacturing costs and clinical costs with four programs now in the clinic versus one clinical program in Q2 2020.

General & Administrative (G&A) expenses were $6.5 million for the quarter ended June 30, 2021, compared to $3.2 million for the second quarter of 2020. This $3.3 million increase in G&A expense was primarily due to increased non-cash stock-based compensation expense, legal and professional fees and costs associated with operating as a public company.

Net loss was $15.6 million or a loss per share of $0.92 (basic and diluted), for the quarter ended June 30, 2021, compared to a net loss of $6.5 million or a loss per share of $3.53 (basic and diluted) for the quarter ended June 30, 2020.

CONFERENCE CALL AND WEBCAST

F-star will host a conference call today, August 12, 2021, beginning at 9:00 AM EDT. To join the webcast, go to our website. To join by phone, participants may dial 1-833-471-0868 in the US/Canada or 1-914-987-7751 for International calls or 0800 0288438 or 0203 1070289 for the United Kingdom, at least 10 minutes prior to the start of the call.

A recording of the conference call will be available on the ‘Events & Presentations’ section of the Company’s website at www.f-star.com from August 13, 2021.

On August 12, 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 second quarter 2021 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, AUG 12, 2021, View Source [SID1234586435]).

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Recent Events & Highlights

Announced completion of enrollment in the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3.0 mg cytisinicline dosed 3 times daily (TID) compared to placebo in adult smokers
Awarded grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) for the evaluation of cytisinicline in cessation of nicotine e-cigarette use
Issued two new patents from the United States Patent and Trademark Office covering the novel 3.0 mg TID cytisinicline dosing regimen
Closed financing with gross proceeds of $23 million, prior to deducting underwriting discounts and offering expenses
"In the second quarter, we continued to demonstrate our commitment to stakeholders by delivering on key milestones that advance our clinical program, and ultimately, cytisinicline’s potential ability to help millions of people who struggle with nicotine addiction to live healthier lives," commented John Bencich, Chief Executive Officer of Achieve. "We will remain committed to the execution of the combustible cigarette cessation program, while in parallel preparing for our anticipated expansion into the e-cigarette cessation indication in partnership with the NIH."

Phase 3 ORCA-2 Trial Fully Enrolled

The Phase 3 ORCA-2 trial completed enrollment of 810 adult smokers at 17 clinical sites in the United States. The participants have been randomized to one of three study arms to determine the efficacy and safety of cytisinicline administered for either six or twelve weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment in the six and twelve-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. Topline ORCA-2 data results are expected to be reported within the first half of 2022.

Awarded Grant from NIH for Nicotine e-cigarette Cessation

Achieve announced that it has been awarded a grant from the NIH to evaluate the use of cytisinicline as a treatment for cessation of nicotine e-cigarette use. The initial grant will be used to complete key clinical and regulatory activities enabling the next stage of the grant award and initiation of the Phase 2 ORCA-V1 clinical study evaluating cytisinicline in approximately 150 adult nicotine e-cigarette users in the United States.

Patents Issued for 3.0 mg TID Dosing Regimen

Achieve announced that the United States Patent and Trademark Office has 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 U.S. Food and Drug Administration (FDA), Achieve anticipates these patents would be included in the FDA’s Orange Book, which lists approved drugs and related patent and exclusivity information.

Completed $23 Million Financing

In May 2021, Achieve announced the closing of an underwritten public offering of 3,285,714 shares of its common stock at a public offering price of $7.00 per share, which includes the exercise in full by the underwriters of their overallotment option to purchase additional shares of common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $23.0 million.

Financial Results

As of June 30, 2021, the company’s cash, cash equivalents, and restricted cash was $42.1 million. Total operating expenses for the three and six months ended June 30, 2021 were $11.3 million and $19.3 million, respectively. Total net loss for the three and six months ended June 30, 2021 was $11.3 million and $19.3 million, respectively.

As of August 12, 2021, Achieve had 9,452,223 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30pm Eastern time today, Thursday, August 12, 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 8694398. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On August 12, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the second quarter of 2021 (Press release, Molecular Templates, AUG 12, 2021, View Source [SID1234586453]).

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"We continue to make progress on advancing our wholly owned pipeline of next-generation ETBs and our existing partnerships. We reached an important milestone recently with initiation of clinical development of MT-6402 (targeting PD-L1 via dual mechanisms) which is the first of our third generation ETBs to enter the clinic," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "With regard to TAK-169, we are now looking forward to continuing clinical development, having assumed full rights to this asset from Takeda. We expect the second half of 2021 to be busy, with clinical data anticipated on MT-5111, TAK-169, and MT-6402 as well as further progress on our earlier stage programs."

Company Highlights and Upcoming Milestones

Corporate

On August 4, 2021, MTEM assumed full rights to TAK-169 from its former co-development partner, Takeda, including full control of TAK-169 clinical development.
On April 5, 2021, MTEM announced the decision to discontinue development of MT-3724, MTEM’s only first-generation ETB. MTEM will focus on the clinical development of next-generation ETBs MT-5111, TAK-169, and MT-6402, as well as advancing next-generation preclinical ETB candidates against targets including CTLA-4, CD20, SLAMF-7, CD45, TROP2 and TIGIT.
MTEM had three presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which took place virtually from April 10-15, 2021:
MT-5111 (interim Phase 1 data as of December 2020), abstract CT130, titled "Phase 1 study of the novel immunotoxin MT-5111 in patients with HER-2+tumors."
MT-6402 (preclinical data), abstract 1628, titled "Engineered toxin bodies targeting PD-L1 to alter tumor immunophenotypes and deliver broad antigenic diversity and patient coverage."
CTLA-4 ETB (preclinical data), abstract 1627, titled "Preclinical characterization of a novel CTLA-4-targeted ETB for direct Treg depletion."
MTEM provided a corporate update and participated in 1-on-1 investor meetings at the Ladenburg Thalmann 2021 Healthcare Conference, which took place July 13-14, 2021.
MT-5111 (HER2 ETB)

The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment. Details of the study were presented at AACR (Free AACR Whitepaper) in April.
The HER2-positive breast cancer expansion cohort is planned to begin in 3Q21 at a dose of 10 mcg/kg (anticipated to be a therapeutic dose level), pending adequate safety data. Dose escalation will continue to determine the recommended Phase 2 dose while the breast cancer expansion cohort collects efficacy and safety data.
Additional data from both the dose escalation portion of the study and the metastatic breast cancer dose expansion cohort are expected in 4Q21.
TAK-169 (CD38 ETB)

On August 4, 2021, MTEM assumed full rights to TAK-169 from its former co-development partner, Takeda, including full control of TAK-169 clinical development, per the terms of the terminated collaboration agreement with Takeda. MTEM will continue conducting the ongoing Phase 1 study for TAK-169 in relapsed/refractory multiple myeloma. This study, which started dosing in February 2020, had a temporary pause in the activation of new study sites and new patient enrollment (along with most of Takeda’s other early-stage studies) due to COVID-19 and was re-initiated in 4Q20.
As previously disclosed, Takeda had enrolled and treated four subjects in the Phase 1 study. Pharmacodynamic activity was noted in the subjects, all treated at the starting dose of 50 mcg/kg. Clearance of natural killer (NK) cells in peripheral blood was observed in all subjects with a maximal reduction of peripheral NK cells of 56%, 85%, 88%, and 92%, respectively, after the first dose. The subject with 56% reduction in NK cells exhibited a low percentage of CD38+ NK cells. These values appear comparable to the reported maximal peripheral NK clearance seen with CD38-targeting antibodies at receptor-saturating doses. The geometric mean of Cmax in these four subjects appears lower than the predicted EC50 observed in patient-derived ex vivo cell-kill assays but above in vitro EC50 values in multiple myeloma cell-lines.
MTEM expects to provide an update on the Phase 1 study in 4Q21.
MT-6402 (PD-L1 ETB with antigen seeding)

In July 2021, MTEM dosed its first subject in a Phase 1 study of MT-6402. MT-6402 is the first of MTEM’s 3rd generation ETBs to enter the clinic. MT-6402 was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of the PD-L1 antibodies.
The Phase 1 study is a multi-center, open-label, dose escalation and dose expansion trial in the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment will be eligible to screen for enrollment. The starting dose is 16 mcg/kg.
Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts.
MTEM expects to provide an update on the Phase 1 study in 4Q21.
Research

MTEM expects to initiate a Phase 1 study for an ETB targeting CTLA-4 in 2022.
Several other wholly owned ETB candidates are in preclinical development against targets including CD20, SLAMF-7, CD45, TROP2, and TIGIT.
In 2021, MTEM expects to present preclinical data on ETB candidates at medical and scientific conferences.
Financial Results

The net loss attributable to common shareholders for the second quarter of 2021 was $15.6 million, or $0.28 per basic and diluted share. This compares with a net loss attributable to common shareholders of $31.2 million, or $0.68 per basic and diluted share, for the same period in 2020.

Revenues for the second quarter of 2021 were $15.1 million, compared to $6.9 million for the same period in 2020. Revenues for the second quarter of 2021 were comprised of revenues from collaborative research and development agreements with Takeda, Vertex and Bristol Myers Squibb. Total research and development expenses for the second quarter of 2021 were $21.1 million, compared with $30.4 million for the same period in 2020. Total general and administrative expenses for the second quarter of 2021 were $8.9 million, compared with $6.4 million for the same period in 2020.

As of June 30, 2021, MTEM’s cash and investments totaled $200.7 million. MTEM’s current cash and investments are expected to fund operations into the second half of 2023.