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Calliditas Therapeutics has resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of approximately SEK 324 million

On August 12, 2021 Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm – CALTX; Nasdaq – CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, reported, in accordance with the Company’s press release earlier today, the closing of a directed share issue consisting of 2,400,000 common shares at a price of SEK 135 per share (the "Issue") (Press release, Calliditas Therapeutics, AUG 12, 2021, View Source [SID1234586456]). The Issue will raise proceeds for the Company of approximately SEK 324 million before transaction costs. The subscription price in the Issue has been determined through an accelerated book building procedure.

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The Issue in brief

The Board of Directors of Calliditas has, in accordance with the issue authorization granted by the Annual General Meeting on May 27, 2021, and as indicated in the Company’s press release on earlier today, resolved on a directed share issue of 2,400,000 new shares at a subscription price of SEK 135 per share, consequently raising gross proceeds of approximately SEK 324 million. The subscription price in the Issue has been determined through an accelerated book building procedure which is why the Board of Directors’ assessment is that the subscription price is in accordance with market conditions. The reasons for the deviation from the shareholders’ preferential rights are to raise capital for the development of ongoing projects in a time and cost-effective manner. Moreover, the Company will further strengthen the shareholder base with Swedish and international institutional investors and sector specialist investors through the Issue.

The Company intends to use the net proceeds from the Issue for:

ongoing clinical development;
pre-commercial development in the United States;
commercial activities for Nefecon, if approved for marketing by the FDA later this year; and
general corporate purposes.
The Issue will entail a dilution of approximately 4.6 percent of the number of shares and votes in the Company. Through the Issue, the number of outstanding shares and votes will increase by 2,400,000, from 49,941,584 to 52,341,584. The share capital will increase by SEK 96,000, from SEK 1,997,663.36 to SEK 2,093,663.36.

In connection with the Issue, the Company has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 90 days. In addition, members of the Board of Directors and management of Calliditas, who owns shares or warrants, have, in connection with the Issue, agreed not to sell any shares in the Company during a lock-up period of 90 days subject to customary exceptions.

Advisers

In conjunction with the Issue, the Company has engaged Carnegie Investment Bank AB (publ) and Jefferies GmbH as Joint Global Coordinators and Joint Bookrunners, and Kempen & Co as Joint Bookrunner (together the "Banks"). Vinge act as legal adviser to the Company and Baker McKenzie act as legal adviser to the Banks.

Phio Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Update

On August 12, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the quarter ended June 30, 2021 and provided a business update (Press release, Phio Pharmaceuticals, AUG 12, 2021, View Source [SID1234586455]).

"The first half of 2021 was just the start of what promises to be an exciting period in our development of the INTASYL enabled immunotherapy compounds across our pipeline. Over the past several months, we have generated positive new preclinical data from different studies that support the initiation of two first-in-human studies of our lead asset PH-762, an INTASYL compound that targets the checkpoint protein PD-1, in cancer patients. Looking ahead, we are finalizing the studies required for the regulatory submissions for each program and expect to be in a position to initiate both studies in the first half of 2022," said Dr. Gerrit Dispersyn, President and CEO of Phio. "Overall, we are very excited by the overwhelmingly positive data generated by our pipeline of INTASYL based product candidates. This data shows that the INTASYL platform is a valuable alternative to other direct therapeutic approaches, but can also be used to improve cell based immunotherapy products."

Quarter in Review and Recent Corporate Updates

Presented a continuous stream of positive data from preclinical studies exploring the flexibility and application of INTASYL in the field of immuno-oncology at leading scientific conferences held during the second quarter of 2021:
Announced positive new data at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that provide further evidence on the utility of the INTASYL self-delivering RNAi therapy platform to target multiple proteins and provide evidence of the synergy of the Company’s pipeline products in the field of immuno-oncology. These in vivo data showed that INTASYL specifically dual-targeting BRD4 and PD-1 elicited complete tumor responses in an in vivo hepatoma model, and significantly outperformed the efficacy of small molecule and antibody treatments towards the same targets.
Announced positive in vivo data at the 24th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) showing that PH-762 can reprogram HER2-targeted CAR-T cells (HER2CART) and significantly enhance their antitumor efficacy in solid tumors, compared to untreated HER2CART cells.
Announced new in vivo data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 showing that intratumoral (IT) treatment with PD-1 targeting INTASYL (mPH-762) inhibits tumor growth in a dose dependent fashion in both PD-1 responsive and refractory models.
Upcoming Pipeline Milestones

Expect to initiate a first-in-human clinical study on the use of PH-762 using direct drug therapy (IT) administration for patients with advanced melanoma in the first quarter of 2022.
Expect to initiate a first-in-human clinical study on the use of PH-762 and tumor infiltrating lymphocytes (TILs) in adoptive cell therapy (ACT) in patients with advanced melanoma in the second quarter of 2022.
Additional data publications on the Company’s pipeline programs.
Financial Results

Cash Position

At June 30, 2021, the Company had cash of $29.4 million as compared with $14.2 million at December 31, 2020. The Company expects its current cash will be sufficient to fund currently planned operations to the second quarter of 2023.

Research and Development Expenses

Research and development expenses were approximately $1.7 million for the quarter ended June 30, 2021, compared to approximately $0.8 million for the quarter ended June 30, 2020. The increase is primarily due to manufacturing costs and fees for the required preclinical studies in support of the Company’s planned clinical trials for PH-762 as compared to the same period in the prior year. The Company expects its research and development expenses to continue to increase in support of, and as the Company commences its clinical trial activities with PH-762.

General and Administrative Expenses

General and administrative expenses were approximately $1.0 million for the quarter ended June 30, 2021, compared to approximately $0.9 million for the quarter ended June 30, 2020. The increase is primarily due to an increase in stock-based compensation expense as no equity awards were granted in the prior year period.

Net Loss

Net loss was $2.7 million, or $0.20 per share, for the quarter ended June 30, 2021, compared with $1.7 million, or $0.34 per share, for the quarter ended June 30, 2020. The increase in net loss was primarily attributable to the increase in research and development expenses related to the Company’s preclinical activities in preparation for the start of its clinical trials with PH-762, as described above. The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of the Company’s capital raise activities as compared to the prior year period.

CASI Pharmaceuticals Announces Second Quarter 2021 Financial Results

On August 12, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the second quarter of 2021 (Press release, CASI Pharmaceuticals, AUG 12, 2021, View Source [SID1234586454]).

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are pleased to report $7.1 million EVOMELA revenues for the quarter. Based on the current trend, we are revising our guidance for full-year 2021 revenue growth to exceed 80% over 2020. We are proud of our commercial franchise execution for EVOMELA and have expanded to over 100 FTEs on the commercial and marketing teams. In addition to the continued EVOMELA revenue growth, we achieved dosing of first patient of CID-103 in our Phase 1 clinical trial for relapse or refectory multiple myeloma. CID-103 has previously shown encouraging preclinical efficacy, a favorable preclinical safety profile, and greater antibody-dependence cellular cytotoxicity activity over other anti-CD38 mAbs, and we are hopeful this will translate into patient benefit."

Dr. He continued, "We are thrilled with the progress we continue to see throughout our hematology oncology pipeline. Our partner, Juventas, has completed CNCT19’s (CD19 CAR-T) Phase 1 studies of B-ALL and B-NHL in China. The Phase 2 B-NHL and B-ALL registration studies of CNCT19 are currently enrolling in China. Additionally, BioInvent recently announced that the China National Intellectual Property Administration (CNIPA) has issued a notice of allowance, informing the company that a patent application relating to the anti-FcγRllB antibody BI-1206 is expected to be granted. Together with BioInvent we plan to continue to develop BI-1206 in both hematological malignancies and solid tumors, with CASI responsible for development and commercialization in Greater China."

Second Quarter 2021 Financial Results

Revenues consist of product sales of EVOMELA that launched during August 2019. Revenue was $7.1 million for the three months ended June 30, 2021 compared to $2.6 million for the three months ended June 30, 2020. Revenues increased by 173% in the second quarter of 2021 as compared to same quarter in 2020 due to the continued growth in EVOMELA sales.

Costs of revenues were $2.9 million for the three months ended June 30, 2021, compared to $2.5 million for the three months ended June 30, 2020, which includes royalty payment of $1.4 million and $0.5 million for the same period. Costs of revenues excluding royalty were $1.5 million and $2.0 million for the three months ended June 30, 2021, and 2020. Costs of revenues, excluding royalty as a percentage of revenues, decreased significantly in the three months ended June 30, 2021, compared within the three months ended June 30, 2020, due to the new alternate manufacturer now in place, resulting in a considerable decrease in the unit cost of inventories of EVOMELA.

General and administrative expenses for the three months ended June 30, 2021 were $5.4 million, compared with $4.1 million for the three months ended June 30, 2020.

Selling and marketing expenses for the three months ended June 30, 2021 were $3.4 million, compared with $1.6 million for the three months ended June 30, 2020. The increase in selling and marketing expenses was due to expansion of sales team in China in 2021.

Acquired in-process R&D expenses for the three months ended June 30, 2021 was $1.06 million, compared to $0 million for the three months ended June 30, 2020. In June 2021, the Company achieved the First-Patient-In (FPI) in the Phase 1 dose escalation and expansion study of CID-103, and made $750,000 milestone payment and accrued €250,000 ($305,000) payment under the terms of the agreement.

Net loss for the three months ended June 30, 2021 was $6.7 million compared to $8.5 million for the three months ended June 30, 2020 due to significant revenue increase. As of June 30, 2021, CASI had cash and cash equivalents of $60.4 million compared to $57.1 million as of December 31, 2020.
Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, can be found at www.casipharmaceuticals.com.

Conference Call

The Company will host a conference call reviewing the second quarter highlights today at 8:00 a.m. ET. The conference call can be accessed by dialing (833) 420-0382 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), 58086567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 5639775. Participants dialing in via International Toll-Free Service (ITFS) numbers will be required to provide the following passcode to join the conference call: 8336474459, 6025859887.

This call will be recorded and available for replay by dialing (800) 859-2056 (U.S.) or (404) 537-3406 (international) and enter 5639775 to access the replay.

Molecular Templates, Inc. Reports Second Quarter 2021 Financial Results

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]).

"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.

Poseida Therapeutics Reports Program Updates and Financial Results for the Second Quarter of 2021

On August 12, 2021 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported program updates and financial results for the second quarter ended June 30, 2021 (Press release, Poseida Therapeutics, AUG 12, 2021, View Source [SID1234586451]).

"We made significant progress in the second quarter of 2021, advancing our science and operational capabilities and setting the stage to deliver on multiple key milestones," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida. "We are excited for the second half of the year when we plan to generate and report additional data on P-PSMA-101, our first solid tumor CAR-T; file two INDs for our fully allogeneic CAR-T programs, P-BCMA-ALLO1 for multiple myeloma, and P-MUC1C-ALLO1 for multiple solid tumor indications; update on our BCMA franchise later in the year and advance our in vivo gene therapy pipeline."

Poseida Therapeutics reported program updates and financial results for the second quarter ended June 30, 2021.

Program Updates
BCMA Programs
P-BCMA-101 is an autologous CAR-T product candidate currently in an ongoing Phase 1 dose expansion trial and Phase 2 trial in development for the treatment of relapsed/refractory multiple myeloma. Phase 1 dose expansion enrollment continues and the Company expects to provide an update on this program later in 2021.

P-BCMA-ALLO1, the Company’s first allogeneic CAR-T product candidate, is in development for the treatment of relapsed/refractory multiple myeloma. The program is proceeding as planned with an IND filing and initiation of a Phase 1 clinical trial on track for the third quarter of 2021.

PSMA Program
P-PSMA-101 is a solid tumor autologous CAR-T product candidate being developed to treat patients with metastatic castrate-resistant prostate cancer (mCRPC) currently in an ongoing Phase 1 dose escalation trial, with an additional update on the program expected later in the third quarter of 2021.

MUC1-C Program
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in preclinical development with the potential to treat a wide range of solid tumors, including breast and ovarian cancers. P-MUC1C-ALLO1 is proceeding as planned, with an anticipated IND filing and initiation of Phase 1 clinical trial by the end of 2021.

Liver-Directed Gene Therapy Program
P-OTC-101 is the Company’s first liver-directed gene therapy program for the in vivo treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene, a condition characterized by high unmet medical need. The Company is currently evaluating whether to modify the P-OTC-101 program to move to the fully non-viral nanoparticle delivery system, which could shift timelines. The Company will update expected timing on program advancement once that evaluation is complete.

Other Operational Updates and Upcoming Events

Addition of Cynthia Collins to Board of Directors
In July, the Company announced the appointment of biotechnology industry veteran Cynthia Collins to its Board of Directors, a recognized leader in cell and gene therapies with broad expertise in gene engineering, oncology and hematology.

Ms. Collins most recently served as the CEO of Editas Medicine, Inc., previously having served as the CEO of Human Longevity, Inc.; the CEO/GM of the Cell Therapy and Lab Business of General Electric’s Healthcare Life Sciences; and the CEO of Clarient Diagnostics, Inc. Ms. Collins received a B.S. degree in Microbiology from the University of Illinois, Urbana and an MBA from The University of Chicago Booth School of Business. She is a member of the board of directors at DermTech, Inc., Certara, Inc., Biocare Medical, LLC, and Triumvira Immunologics, Inc., and previously served on the board for the ARM Foundation for Cell and Gene Medicine and Alliance for Regenerative Medicine.

Interim Update on Data from Phase 1 P-PSMA-101 Clinical Trial to be Presented at CAR-TCR Summit
The Company plans to provide an update from the Phase 1 P-PSMA-101 clinical trial to be presented by CEO, Eric Ostertag, at the 6th Annual CAR-TCR Summit virtual meeting at 10:00 am ET on August 31, 2021, entitled, "P-PSMA-101 is a High-Tscm Autologous CAR-T Targeting PSMA Producing Exceptionally Deep and Durable Responses in Castration-Resistant Metastatic Prostate Cancer."

Financial Results for the Second Quarter 2021
Research and Development Expenses
Research and development expenses were $36.0 million for the second quarter ended June 30, 2021, compared to $25.2 million for the same period in 2020. For the six months ended June 30, 2021, research and development expenses were $65.1 million, compared to $48.6 million for the same period in 2020. The increase was primarily due to increased stock-based compensation expense, headcount, external costs related to our preclinical programs and clinical stage programs, including the ongoing enrollment and manufacturing associated with our P-BCMA-101 and P-PSMA-101 clinical trials, and internal costs related to facilities development.

General and Administrative Expenses
General and administrative expenses were $8.9 million for the second quarter ended June 30, 2021, compared to $4.2 million for the same period in 2020. General and administrative expenses were $17.2 million for the six months ended June 30, 2021, compared to $9.1 million for the same period in 2020. The increase was primarily due to increased stock-based compensation expense, headcount and professional fees associated with operating as a publicly traded company.

Net Loss
Net loss was $45.7 million and $84.0 million for the three and six months ended June 30, 2021, respectively, and $30.4 million and $59.2 million for the three and six months ended June 30, 2020, respectively.

Cash Position
As of June 30, 2021, cash, cash equivalents and short-term investments were $237.3 million.