On August 1, 2022 OriCell Therapeutics (Shanghai) Co., Ltd. ("OriCell" or "the Company") reported the completion of Series B financing totaling over US$120 million (Press release, OriCell Therapeutics, AUG 1, 2022, View Source [SID1234617197]). This round of financing was jointly led by Qiming Venture Partners and Quan Capital with participation by several leading international and Chinese investment funds, as well as existing shareholder C&D Emerging Capital. The new funding will go toward the development of OriCell’s cell therapy pipeline, and Company’s proprietary discovery platform, as well as the construction of a manufacturing plant for both clinical and commercial purposes.

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Helen Yang, Chairman and CEO of OriCell, stated, "We are grateful to our new and existing investors for their continued support in OriCell. We have achieved a number of significant milestones in terms of clinical development of our CAR-T and partnered bispecific antibody programs, as well as continued to strengthen our senior management team. We look forward to delivering more innovative discoveries and clinical milestones in the next three years. In today’s open, inclusive, and dynamic innovative pharmaceutical ecosystem in China, we endeavor to become a world leading cell therapy company with a broad vision that can integrate seamlessly into the global market."

OriCell’s Investigational New Drug (IND) submission for Ori-C101, Company’s first internally developed CAR-T product targeting GPC3 for the treatment of advanced liver cancer, was accepted by the National Medical Products Administration (NMPA) of China in June of this year. In data published at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, Ori-C101 demonstrated superior safety and efficacy in patients with GPC3-positive advanced liver cancer with an objective response rate (ORR) of 44% and disease control rate (DCR) of 78%. The longest follow-up thus far is more than 22 months, with additional follow-ups ongoing.

OriCAR-017, China’s first GPRC5D CAR-T product developed by OriCell for the treatment of relapsed and refractory multiple myeloma (RRMM) confirmed the product’s potential with clinical results from the investigator-initiated phase I trial (POLARIS) was presented in an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper)2022 annual meetings, respectively. In all patients, the majority of adverse events (AE) were transient, manageable, and reversible. Only Grade 1/2 cytokine release syndrome (CRS) was observed with no dose limiting toxicity (DLT), neurotoxicity, or AE-related death. Responses were durable and deepened over time with 100% ORR and 100% MRD negative rate, including in 5 prior BCMA CAR-T relapsed patients. All patients were progression-free and followed up without additional therapy by the cutoff date of April 30, 2022. Presently, OriCell is accelerating its registration and clinical development in China and the United States.

An exclusive global license agreement for OriBs-001 (ATG101) was reached with Antengene in 2019. OriBs-001 (ATG101) is a PD-L/4-1BB bispecific antibody and has received the implied approval from the Center for Drug Evaluation (CDE) in China in March this year after receiving IND from the U.S. Food and Drug Administration (FDA) and Clinical Trials Notification (CTN) from the Australian Therapeutic Goods Administration (TGA).

In March this year, Dr. Weidong Cui joined the company as Chief Technology Officer. Dr. Cui has more than 20 years of experience in process development, GMP production and commercial operation of cell therapy drug products. As the former CTO at Fosun Kite, he has led the team to successfully complete the GMP production, IND registration, and NDA registration of the first CAR-T drug in China.

On August 1, 2022 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, and Chief Financial Officer, Steven Binder will participate in the BTIG Biotechnology Conference taking place on Monday, August 8 – Tuesday, August 9, 2022 (Press release, Mannkind, AUG 1, 2022, View Source [SID1234617196]).

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This conference is being hosted by BTIG, a global financial services firm specializing in institutional trading, investment banking, research, and related brokerage services. BTIG’s Corporate Access program hosts client events across the consumer, digital assets, energy and infrastructure, financials, healthcare, real estate, and technology sectors.

Management will be participating in one-on-one meetings throughout the event. To join the conference and arrange a meeting with management, please email [email protected].

On August 1, 2022 Fresenius reported that The U.S. Food and Drug Administration (FDA) has accepted for review Fresenius Kabi’s Biologics License Application (BLA) for MSB11456, a biosimilar candidate of Actemra*(tocilizumab) (Press release, Fresenius, AUG 1, 2022, View Source [SID1234617195]). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline in the US. The BLA includes presentations for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.

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*Actemra is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

On August 1, 2022 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the second quarter of 2022 (Press release, DBV Technologies, AUG 1, 2022, View Source [SID1234617194]). The quarterly financial statements were approved by the Board of Directors on July 29, 2022.

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Financial Highlights for the Second Quarter and the Six Months Ended June 30, 2022:1

Cash and cash equivalents were $248.0 million, as of June 30, 2022, compared to $77.3 million as of December 31, 2021, and $74.1 million as of March 31, 2022. The net increases of respectively $173.9 million and $170.7 million for the quarter and six months ended June 30, 2022, were mostly comprised of a $195.3 million net cash flow received from the ATM Offering in May 2022 for $14.1 million; net of transaction costs and PIPE Offering in June 2022 for $181.2 million; net of transaction costs as well as a $27.1 million cash flow received following the reimbursement of the 2019, 2020 and 2021 Research Tax Credit (French Crédit Impôt Recherche, or CIR) offset by a $(38.9) million cash utilization in operating activities; and the effect of exchange rates on cash and cash equivalents for $(12.6) million.

Excluding the effect of second quarter financing and reimbursement of the Research Tax Credit, the cash used in operating activities decreased by 42% in U.S. GAAP and 44% in IFRS between the first half of 2021 and 2022, reflecting the

1The Company’s interim consolidated financial statements for the six months ended June 30, 2022, are prepared in accordance with both generally accepted accounting principles in the U.S. ("U.S. GAAP") and International Financial Reporting Standards ("IFRS") as adopted by the European Union. Unless otherwise indicated, the financial figures presented in the Q2 Financial Highlights comply with both U.S GAAP and IFRS financial statements. Differences between U.S. GAAP and IFRS consolidated financial statements are mainly due to discrepancies arising from the application of lease accounting standards.
Company’s continued implementation of budget discipline measures.

Cash and Cash Equivalents

Based on its current assumptions, DBV expects that its current cash and cash equivalents will support its operations several months beyond the current projected completion of VITESSE, the planned Phase 3 clinical study of the modified Viaskin Peanut patch in peanut-allergic children ages 4 years and older. DBV continues to engage in productive dialogue with the FDA on the key elements of the VITESSE protocol. As previously disclosed, the Company will communicate key elements of the VITESSE trial design and projected timelines once this process has concluded.

Operating Income is primarily generated from DBV’s Research Tax Credit (French Crédit Impôt Recherche, or CIR) and from revenue recognized by DBV under its collaboration agreement with Nestlé Health Science. Operating income was $4.1 million for the six months ended June 30, 2022, compared to $1.5 million for the six months ended June 30, 2021. The variation in operating income is primarily attributable to the revision of the revenue recognized under Nestlé’s collaboration agreement conducted as part of the existing contract, as the Company updated the measurement of progress of its Phase II APTITUDE milk-diagnostic tool clinical study.

Operating Expenses for the three months ended June 30, 2022, were $(25.4) million, compared to $(29.6) million for the three months ended June 30, 2021, each under U.S. GAAP or -14%. For the six months ended June 30, 2022, operating expenses were $(44.7) million under U.S. GAAP and $(44.3) million under IFRS, compared to $(62.2) million and $(62.0) million under U.S. GAAP and IFRS respectively, for the six months ended June 30, 2021. DBV has continued to practice financial diligence and implemented further cost containment strategies.

Employee-related costs decreased by $3.8 million, from $15.9 million for the six months ended June 30, 2021, to $12.1 million for the six months ended June 30, 2022 – a 23.8% decrease, compared to a 21% decrease of the average number of headcounts between the two periods (88 and 111 full-time equivalent employees for the six months ended June 30, 2022 and 2021, respectively). As of June 30, 2022, DBV had 86 employees.

Net Loss and Net Loss Per Share

For the three months ended June 30, 2022, net loss was $(23.0) million compared to a net loss of $(30.7) million for the comparable period in 2021.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(0.35) and $(0.56) for the three months ended June 30, 2022 and 2021, respectively.

For the six months ended June 30, 2022, net loss was $(39.7) million and $(39.5) million under U.S. GAAP and IFRS, respectively. Net loss per share was $(0.66) under U.S. GAAP and $(0.65) under IFRS.

Monthly Information Regarding the Total Number of Voting Rights and Total Number of Shares of the Company as of June 30, 2022:

* Total net = total number of voting rights attached to shares – shares without voting rights

The PIPE financing DBV completed in June included the sale of prefunded warrants to purchase up to 28,276,331 ordinary shares. The pre-funded warrants are not included in the number of shares outstanding. If all 28,276,331 pre-funded warrants were exercised, the total number of DBV shares outstanding would be 122,299,010.

Class Action Complaint:

As previously disclosed, a class action complaint was filed in January 2019 in the U.S. District Court, District of New Jersey, alleging that the Company and certain current and former executive officers violated certain U.S. federal securities laws. Plaintiffs filed a Third Amended Complaint on September 30, 2021. On July 29, 2022, the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended Complaint. The Company believes that the allegations contained in the complaint are without merit and will continue to defend the case vigorously.

2Unaudited financial statements prepared in accordance with generally accepted accounting principles in the U.S. ("U.S. GAAP").
3Unaudited financial statements prepared in accordance with International Financial Reporting Standards ("IFRS") as adopted by the European Union.

On August 1, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported that it will host a conference call on August 15, 2022, at 4:30 PM Eastern Time to discuss results for its second quarter ended June 30, 2022 (Press release, Panbela Therapeutics, AUG 1, 2022, View Source;utm_medium=rss&utm_campaign=panbela-schedules-conference-call-on-8-15-22-to-report-2022-2nd-quarter-financial-results [SID1234617193]).

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About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months which is final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.