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 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases, reported that the company will release its 2022 second quarter financial results after the market closes on Monday, August 15, 2022 (Press release, CohBar, AUG 1, 2022, View Source [SID1234617210]). Management will host a conference call and webcast at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

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A simultaneous webcast of the call will be accessible via the Investors section of the CohBar website at www.cohbar.com.
For individuals participating in the Investor Call or webcast, please call or login to the conference audio approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on August 15, 2022, through 11:59 p.m. Eastern Time on September 5, 2022. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13730421. The audio recording will also be available at www.cohbar.com during the same period.

On August 1, 2022 Biosight Ltd., a pharmaceutical development company focused on the development of innovative therapeutics for hematological malignancies and disorder, reported that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to aspacytarabine (BST-236), an investigational novel antimetabolite, for the treatment of myelodysplastic syndromes, in addition to the Orphan Drug Designation granted in 2019 for aspacytarabine for the treatment of acute myeloid leukemia (AML) (Press release, BioSight, AUG 1, 2022, View Source [SID1234617226]).

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Following the encouraging single-agent efficacy and safety profile of aspacytarabine in the recently completed Phase 2b trial in front-line treatment of AML patients unfit for standard induction chemotherapy, aspacytarabine development program is being expanded to second-line treatment of AML and MDS in two ongoing Phase 2 clinical trials, one in the US and Israel and one in France in collaboration with the European cooperative group, GFM. In addition to the monotherapy development programs, a Phase 1/2 trial of aspacytarabine in combination with the Bcl2 inhibitor, venetoclax, for the treatment of AML patients unfit for standard chemotherapy will be launched in the coming weeks.

"We are very pleased to have received from the FDA the Orphan Drug Designation for aspacytarabine for the treatment of MDS, which adds to the designation granted already for the treatment of AML" said Dr. Ruth Ben Yakar, CEO of Biosight. "The accumulating clinical data from more than a hundred patients treated to date with aspacytarabine monotherapy in four clinical trials, suggest that aspacytarabine, with a differentiated mechanism that enables high-dose chemotherapy with reduced toxicity, has the potential to transform standard of care for AML and MDS patients".

Orphan Drug Designation by the FDA entitles Biosight to seven years of market exclusivity for the use of aspacytarabine for the treatment of MDS, if approved, plus significant development incentives, including tax credits related to clinical trial expenses, an exemption from the FDA-user fee, and FDA assistance in clinical trial design.

About Aspacytarabine (BST-236)

Aspacytarabine is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. Cytarabine serves as the backbone of AML and MDS therapy for over 45 years due to its superior efficacy, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities, which significantly limit its use, especially in older and medically compromised patients. Due to its unique pharmacokinetics and metabolism, aspacytarabine enables high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues. As such, aspacytarabine may serve as a superior therapy for AML, MDS, and other hematological malignancies and disorders, including for older adults who are unfit for intensive therapy.

Aspacytarabine was granted FDA Fast Track Designation for the treatment of AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, and Orphan Drug designations from the FDA and EMA, which entitles Biosight to seven and ten years of market exclusivity upon aspacytarabine marketing approval for the treatment of AML in the US and Europe, respectively.

Results from the recently completed Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and single-agent activity, and additional studies are ongoing to evaluate aspacytarabine as a second line treatment for patients with relapsed or refractory MDS or AML. For more information regarding the Phase 2b clinical study of aspacytarabine, please visit www.clinicaltrials.gov.

On August 1, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that it will report its second quarter and first six months of 2022 financial results on Monday, August 8, 2022 after the close of the U.S. financial markets (Press release, Prothena, AUG 1, 2022, View Source [SID1234617285]).

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Consistent with past practice, the Company will not be conducting a conference call in conjunction with this financial results release on August 8.

On August 1, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported a progress update on the GBM AGILE pivotal study (NCT03970447), a global adaptive clinical trial platform designed to evaluate multiple therapies for glioblastoma, to which paxalisib commenced enrolment in January 2021 (Press release, Kazia Therapeutics, AUG 1, 2022, View Source [SID1234617178]).

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Kazia has been advised by the Global Coalition for Adaptive Research (GCAR), the sponsor of the study, that the first stage of the paxalisib arm has completed recruitment. The treatment arm did not meet pre-defined criteria for continuing to a second stage, and patients enrolled in the first stage of the paxalisib arm will therefore continue on treatment as per protocol, and in follow-up, until completion of the final analysis, which Kazia anticipates receiving in 2H CY2023, as previously disclosed.

Given that completion of recruitment has now occurred, the study will not open to the paxalisib arm in Germany or China. Kazia will work with its licensing partner to determine the way forward in China, given that country’s general requirement for local data to register a new pharmaceutical product.

All Kazia personnel continue to be blinded to efficacy and safety data from the ongoing study, as required by regulatory authorities, and so the company remains unable to provide analysis or interpretation of the study until follow-up is complete and final data is available.

Kazia CEO, Dr James Garner, commented, "GBM AGILE was designed as an adaptive study, with the potential to follow a range of different paths to completion. Today’s news defines the remaining trajectory of the study, with modestly positive implications for both costs and timelines, and with some specific consequences for regulatory strategy in China. It does not allow us to draw any meaningful inferences about the outcomes of the study, and indeed it is critical for regulatory purposes that we remain blinded to the evolving data. We look forward to reporting final results in 2H CY2023, as currently planned. In the meantime, we are excited by some of the emerging data in diffuse intrinsic pontine glioma (DIPG) and brain metastases, which have become increasingly important areas of focus for the company and look forward to sharing more detail on those activities in due course."