On November 9, 2021 Xencor reported Novartis terminated its rights to develop vibecotamab, a CD123 x CD3 blood cancer bispecific, which was part of a 2016 collaboration valued at $2.6 billion (Press release, Xencor, NOV 9, 2021, View Source [SID1234595329]).

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Since the collaboration was first forged, Novartis has slowly stepped away from the partnership. In 2019, the Swiss pharma giant backed away from developing XmAb13676, a CD20 x CD3 bispecific antibody, following a strategic pipeline reprioritization. Now, Novartis is terminating rights to the vibecotamab program, effective February 2022.

In 2019, shortly after Novartis dumped development rights to XmAb13676, the other asset was hit with a partial clinical hold by the U.S. Food and Drug Administration. The CD123 x CD3 blood cancer bispecific was assessed in a Phase I study for acute myeloid leukemia. Two patients in the trial died.

CD123 is a tumor-associated antigen overexpressed on the surface of some tumor cells. The CD3 complex is a group of proteins on the surface of T-cells. Multiple companies have taken this approach against leukemia, but results have been less than encouraging.

In 2016, Janssen and Genmab saw a hold placed on their CD123 x CD3 candidate for acute myeloid leukemia. Cellectis also caught a clinical hold on two Phase I trials of its CD123 asset, UCART123.

Xencor announced Novartis’ decision in its third quarter financial report. The company stated that it would continue the ongoing study of vibecotamab, but it no longer intends further internal development of the drug once it is complete.

There is still hope that something from the partnership with Novartis could be salvaged through the development of another asset. Earlier this year, the larger company selected a candidate to develop. The outcome for that study is still off in the future.

Although the partnership with Novartis has taken a significant blow, Xencor could see fruit from a collaboration with Janssen. In October, the two companies entered into a partnership to advance the development of plamotamab and XmAb CD28 bispecific antibody combinations to treat patients with B-cell malignancies. Under terms of that deal, Janssen secured exclusive worldwide development and commercial rights to plamotamab, an investigational tumor-targeted XmAb bispecific antibody, currently in Phase I clinical development as a potential treatment for patients with CD20-expressing hematologic malignancies.

Xencor is paying 20% of costs, including those for a subcutaneous formulation study that is expected to enter clinical studies in 2022. In the meantime, Xencor will continue, at its own expense, the combination study of plamotamab, tafasitamab and lenalidomide.

Xencor is also partnered with Bristol Myers Squibb on the development of potential antibody treatment for COVID-19. The two companies will advance the development of Xencor’s Xtend Fc technology.

On November 9, 2021, (i) Teva Pharmaceutical Finance Netherlands II B.V. ("Teva Finance II"), a wholly owned subsidiary of Teva Pharmaceutical Industries Limited (the "Company"), reported that issued €1,100,000,000 aggregate principal amount of 3.750% Sustainability-Linked Senior Notes due 2027 (the "2027 Euro Notes") and €1,500,000,000 aggregate principal amount of 4.375% Sustainability-Linked Senior Notes due 2030 (the "2030 Euro Notes" and, together with the 2027 Euro Notes, the "Euro Notes"); and (ii) Teva Pharmaceutical Finance Netherlands III B.V (Filing, 8-K, Teva, NOV 9, 2021, View Source [SID1234595238]). ("Teva Finance III" and, together with Teva Finance II, the "Issuers"), a wholly owned subsidiary of the Company, issued $1,000,000,000 aggregate principal amount of 4.750% Sustainability-Linked Senior Notes due 2027 (the "2027 USD Notes") and $1,000,000,000 aggregate principal amount of 5.125% Sustainability-Linked Senior Notes due 2029 (the "2029 USD Notes" and, together with 2027 USD Notes, the "USD Notes" and together with the Euro Notes, the "Notes").

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Teva intends to use the net proceeds from the Notes to (i) fund the announced tender offer for a maximum combined aggregate purchase price (exclusive of accrued and unpaid interest) of up to $4,000,000,000 (equivalent) (upsized from a previously announced cap of $3,500,000,000), (ii) pay fees and expenses in connection therewith, (iii) to fund the repayment of outstanding debt upon maturity, tender offer or earlier redemption and (iv) the extent of any remaining proceeds, for general corporate purposes.

The Euro Notes were issued pursuant to a Senior Indenture, dated as of March 14, 2018 (the "Euro Notes Base Indenture"), by and among Teva Finance II, the Company, as guarantor, and The Bank of New York Mellon, as trustee, as supplemented by the Third Supplemental Indenture, dated as of November 9, 2021 (the "Euro Notes Supplemental Indenture" and, together with the Euro Notes Base Indenture, the "Euro Notes Indenture"), by and among Teva Finance II, the Company, as guarantor, The Bank of New York Mellon, as trustee, and The Bank of New York Mellon, London Branch, as paying agent. The USD Notes were issued pursuant to a Senior Indenture, dated as of March 14, 2018 (the "USD Notes Base Indenture"), as supplemented by the Third Supplemental Indenture, dated as of November 9, 2021 (the "USD Notes Supplemental Indenture" and, together with the USD Notes Base Indenture, the "USD Notes Indenture" and, together with the Euro Notes Indenture, the "Indentures"), in each case, by and among Teva Finance III, the Company, as guarantor, and The Bank of New York Mellon, as trustee.

Interest will be payable on the Notes semi-annually in arrears on May 9 and November 9 of each year, beginning on May 9, 2021, until their maturity dates of May 9, 2027 for the 2027 Euro Notes and the 2027 USD Notes, May 9, 2029 for the 2029 USD Notes and May 9, 2030 for the 2030 Euro Notes. The Euro Notes and the USD Notes are senior unsecured obligations of Teva Finance II and Teva Finance III, respectively, and the Notes are guaranteed on a senior unsecured basis by the Company.

From and including May 9, 2026 (the "Step-up Date"), the interest rate payable on the 2030 Euro Notes and the 2029 USD Notes shall increase by:

(a) 0.125% per annum unless Teva has achieved the Regulatory Submissions Target as of the Testing Date (each as defined in the Euro Notes Supplemental Indenture and the USD Notes Supplemental Indenture);

(b) 0.125% per annum unless Teva has achieved the Product Volume Target as of the Testing Date (each as defined in the Euro Notes Supplemental Indenture and the USD Notes Supplemental Indenture); and

(c) 0.125% per annum unless Teva has achieved the Emission Reduction Target as of the Testing Date(each as defined in the Euro Notes Supplemental Indenture and the USD Notes Supplemental Indenture);

At maturity or upon earlier redemption of the 2027 Euro Notes and/or the 2027 USD Notes (but only if such redemption is on or after the Step-up Date), the following premiums shall be payable on the 2027 Euro Notes and/or the 2027 USD Notes:

(a) 0.150% of the principal amount repaid unless Teva has achieved the Regulatory Submissions Target as of the Testing Date;

(b) 0.150% of the principal amount repaid unless Teva has achieved the Product Volume Target as of the Testing Date; and

(c) 0.150% of the principal amount repaid unless Teva has achieved the Emission Reduction Target as of the Testing Date.

Teva Finance II may redeem the Euro Notes of any series, in whole or in part, at any time or from time to time, upon at least 10 days’, but not more than 60 days’, prior notice delivered to the registered address of each holder of the Euro Notes to be redeemed with a copy of such notice delivered to the trustee and the paying agent. Subject to any adjustments in accordance with the premium payment for the 2027 Euro Notes, the Euro Notes will be redeemable at a redemption price equal to the greater of (1) 100% of the principal amount of the Euro Notes of such series to be redeemed or (2) the sum of the present values of the Remaining Scheduled Payments (as defined in the Euro Notes Indenture) of the Euro Notes of such series being redeemed discounted, on a semi-annual basis (assuming a 360-day year consisting of twelve 30-day months), at the applicable Reinvestment Rate (as defined in the Euro Notes Indenture), plus accrued and unpaid interest thereon, if any to, but not including, the redemption date; provided that if Teva Finance II elects to redeem the 2027 Euro Notes at any time on or after February 9, 2027 (three months prior to the maturity date of the 2027 Euro Notes) or to redeem the 2030 Euro Notes at any time on or after February 9, 2030 (three months prior to the maturity date of the 2030 Euro Notes), Teva Finance II may redeem the such Euro Notes, in whole or in part, at a redemption price equal to 100% of the principal amount of such series of Euro Notes then outstanding to be redeemed, plus accrued and unpaid interest thereon, if any, to, but not including, the redemption date.

Teva Finance III may redeem the USD Notes, of any series, in whole or in part, at any time or from time to time, upon at least 10 days’, but not more than 60 days’, prior notice. Subject to any adjustments in accordance the premium payment for the 2027 USD Notes, the USD Notes will be redeemable at a redemption price equal to the greater of (1) 100% of the principal amount of the USD Notes to be redeemed or (2) the sum of the present values of the Remaining Scheduled Payments (as defined in the USD Notes Indenture) of the USD Notes of such series being redeemed discounted, on a semi-annual basis (assuming a 360-day year consisting of twelve 30-day months), using a discount rate equal to the sum of the Treasury Rate (as defined in the USD Notes Indenture) plus 50 basis points, in the case of the 2027 USD Notes, and 50 basis points, in the case of the 2029 USD Notes, plus in each case accrued and unpaid interest thereon, if any, to, but not including, the redemption date; provided that if Teva Finance III elects to redeem the 2027 USD Notes at any time on or after February 9, 2027 (three months prior to the maturity date of the 2027 USD Notes) or to redeem the 2029 USD Notes at any time on or after February 9, 2029 (three months prior to the maturity date of the USD Notes), Teva Finance III may redeem the USD Notes, in whole or in part, at a redemption price equal to 100% of the principal amount of such series of USD Notes then outstanding to be redeemed, plus accrued and unpaid interest thereon, if any, to, but not including, the redemption date.

The terms of the Indentures, among other things and subject to specified exceptions, limit the ability of (a) the Company and its subsidiaries to (i) create liens upon certain of their property and (ii) enter into sale-leaseback transactions; and (b) the applicable Issuer and the Company to merge, consolidate or sell, lease or convey all or substantially all of their assets. The Indentures provide for customary events of default, which include (subject in certain cases to customary grace and cure periods), among others, nonpayment of principal or interest; breach of other covenants or agreements in the Indentures; acceleration of certain other indebtedness; failure of the Company’s guarantee to be enforceable; and certain events of bankruptcy or insolvency. The offering of the Notes was registered under the Securities Act of 1933, as amended (the "Securities Act"), and is being made pursuant to the Company’s Registration Statement on Form S-3ASR (File No. 333-260519) and the prospectus included therein (the "Registration Statement"), filed by the Company with the Commission on October 27, 2021, the preliminary prospectus supplement relating thereto, dated October 27, 2021, and filed with the Commission on October 27, 2021 pursuant to Rule 424(b)(3) promulgated under the Securities Act and the free writing prospectus related thereto, dated November 2, 2021, and filed with the Commission on November 2, 2021 pursuant to Rule 433 under the Securities Act.

The foregoing summary descriptions of the Euro Notes Base Indenture, Euro Notes Supplemental Indenture, USD Notes Base Indenture, USD Notes Supplemental Indenture and each series of Notes are not complete and are qualified in their entirety by reference to the Euro Notes Base Indenture, the Euro Notes Supplemental Indenture, the form of 2027 Euro Notes, the form of 2030 Euro Notes the USD Notes Base Indenture, the USD Notes Supplemental Indenture, the form of 2027 USD Notes and the form of 2029 USD Notes, which are filed as Exhibits 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7 and 4.8, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

On November 9, 2021 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, reported business highlights and financial results for the third quarter ended September 30, 2021 (Press release, Delcath Systems, NOV 9, 2021, View Source [SID1234595228]).

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Recent Business Highlights

During and since the third quarter Delcath:

Entered a debt facility with Avenue Venture Opportunities Fund, L.P. providing up to $20 million with an initial $15 million funded at closing,
Submitted to and received approval from the FDA for an expanded access protocol for the use of HEPZATO Kit (melphalan hydrochloride for injection/hepatic delivery system) in the treatment of patients with liver dominant metastatic ocular melanoma,
Updated guidance of the Class 2 resubmission of the NDA to mid-year from the end of the first quarter,
Hired 3 senior executives in clinical operations, regulatory and medical affairs to support the resubmission of the NDA and further clinical development of HEPZATO, and
Announced it will host a comprehensive Investor Update event on Thursday, December 2nd, from 10:00am ET – 1:00pm ET covering FOCUS trial results as well as development plans for the use of HEPZATO in the treatment of patients with intrahepatic cholangiocarcinoma and colorectal cancer.
In addition, during the third quarter independent investigators:

Presented three abstracts on the use of Chemosat Hepatic Delivery System with Melphalan in the treatment of metastatic ocular melanoma (mOM) at the 2021 Cardiovascular and Interventional Radiological Society of Europe conference (CIRSE) including,
Safety and toxicity of combining hepatic percutaneous perfusion with ipilimumab plus nivolumab in advanced uveal melanoma: phase 1b of the CHOPIN Trial1
Long-term results of percutaneous hepatic perfusion with melphalan in patients with unresectable liver metastases from uveal melanoma: a multicenter retrospective study2
Safety and efficacy of chemosaturation with percutaneous hepatic perfusion of melphalan for metastatic uveal melanoma: an 8-year retrospective study of 250 interventions in 81 patients3
Published Repeated percutaneous hepatic perfusion with melphalan can maintain long-term response in patients with liver cancers4 in the journal Cardiovascular and Interventional Radiology.
"It’s very exciting to see the initial results of the CHOPIN Trial. These early results in the first trial to combine percutaneous hepatic perfusion with combination immunotherapy show promise with no dose limiting toxicities observed to date. The significant disease control and repeatability of the procedure with limited cumulative toxicity observed in these recent publications is consistent with what we have seen documented from other institutions," said Dr. Johnny John, SVP Clinical Operations and Medical Affairs.

"During the quarter we strengthened our balance sheet and added senior personnel to the Delcath team," said Gerard Michel, CEO of Delcath. "With the additional capital and senior leadership, Delcath has the required resources to accomplish its strategic priorities – the filing of the HEPZATO NDA in mid-2022, preparing for the subsequent US launch when approved, and expanding the development of HEPZATO into additional areas of high unmet need."

Financial Results:

Income Statement Highlights.

Product revenue for the three months ended September 30, 2021 was approximately $522 thousand, compared to $466 thousand for the prior year period from our sales of CHEMOSAT procedures in Europe. Selling, general and administrative expenses were approximately $4.0 million compared to $2.0 million in the prior year quarter. Research and development expenses for the quarter were $3.0 million compared to $3.3 million in the prior year quarter. Total operating expenses for the quarter were $7.0 million compared with $5.3 million in the prior year quarter. Expenses for the quarter included approximately $2.5 million of stock option expense compared to no stock option expense in the prior year quarter.

The Company recorded a net loss for the three months ended September 30, 2021, of $7.1 million, compared to a net loss of $5.0 million for the same period in 2020.

Balance Sheet Highlights.

On September 30, 2021, we had cash, cash equivalents and restricted cash totaling $29 million, as compared to cash, cash equivalents and restricted cash totaling $11.1 million at September 30, 2020. During the three months ended September 30, 2021 and September 30, 2020, we used $16.2 million and $17.8 million, respectively, of cash in our operating activities.

On August 6, 2021 we closed a $20 million venture debt financing transaction with Avenue Venture Opportunities Fund, L.P. ("Avenue Venture Fund"), at which time an initial $15 million tranche of the loan was funded, including $4 million funded into a restricted account to be released upon achievement of certain milestones. The Company may request an additional $5 million tranche of the loan between October 1, 2022 and December 31, 2022, the funding of which will be at Avenue Venture Fund’s discretion.

Also, on August 6, 2021, we amended two existing convertible notes through an extension of the term of the notes until 2024 and lowered the conversion factor in consideration for the notes becoming subordinate to the Avenue Venture Fund debt.

Additional details concerning the Avenue Venture Fund facility and modification of the existing convertible notes are contained in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 11, 2021.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

On November 9, 2021 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, reports financial results for the third quarter 2021 ended September 30, 2021, along with a corporate update (Press release, Oncocyte, NOV 9, 2021, View Source [SID1234595212]).

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"The recently announced clinical launch of our DetermaIO test, via an early access program (EAP), is an important milestone to inform immunotherapy decisions which strengthens Oncocyte’s differentiated position in precision diagnostics," said Ron Andrews, Chief Executive Officer and President of Oncocyte. "We believe that the combination of DetermaIO with our comprehensive genomic profiling test DetermaTx, expected to be launched late in the first quarter of 2022 upon completion of the DetermaIO EAP program, will offer the most complete precision diagnostic solution to inform cancer treatment decisions for the 1.8 million patients diagnosed with cancer in the United States each year and allows us to enter a total available market of $5 billion. This combined offering is further differentiated by its ability to deliver comprehensive treatment decision information while conserving the limited tumor tissue sample available for testing, with industry leading turnaround time. We are very encouraged with the response to our recently announced early access program for DetermaIO, we have begun onboarding the accounts, and are excited to receive our first clinical patient samples in the coming weeks. Our clinical studies have now reported results for over 1,000 patients, validated DetermaIO in four different tumor types, and shown consistent outperformance of the current tests being used to select patients for treatment."

Mr. Andrews continued, "We’ve continued our progress with DetermaRx and, despite significant disruptions in early-stage lung cancer surgeries over the summer due to the surge of the COVID-19 Delta variant, we generated 65% year over year growth in test volume. We also continue to deliver on our two metrics used to measure test adoption during the current market environment: new hospital onboards increased by42 facilities, growing 24% quarter over quarter, and our ordering physicians grew by 66 doctors or 22% quarter over quarter. We have now established a solid install base that is poised to grow our sample volume and revenue once early-stage lung cancer surgeries return to pre-pandemic levels."

"With the issuance of our IP in blood-based monitoring for transplant rejection, we now have a clear path to launching our own LDT test into the large transplant rejection market in the U.S. and Europe. Oncocyte expects to complete 2021 with solid momentum toward our goal of building a compelling and powerful portfolio of molecular diagnostic tests. As a complement to this progress, our recent appointment of Gisela Paulsen as Chief Operating Officer brings additional world-class talent to the experienced leadership team at Oncocyte and comes on board at an important time as we expand our operations to support the anticipated growth ahead."

Third Quarter and Recent Highlights Include:

●Announced the clinical launch of the DetermaIO immunotherapy response prediction test via an early access program.

●Oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) on randomized clinical trial data definitively established DetermaIO as a predictive biomarker of immunotherapy response. In the triple negative breast cancer (TNBC) NeoTRIPaPDL1 study, DetermaIO outperformed 80 other immune signatures.

●Published a peer-reviewed study in the journal Cancers with investigators from leading academic institutions MD Anderson and Yale demonstrating the predictive potential for DetermaIO. Study data showed that DetermaIO demonstrates superior accuracy compared to standard of care PD-L1 immunohistochemistry (IHC) for prediction of a patient’s response to immunotherapy in TNBC. Previous data has been presented in lung, bladder, renal and kidney cancers suggesting a broad pan-cancer utility of the test.

●Strengthened transplant IP portfolio with issuance of a U.S. patent covering digital PCR technology for early detection of organ transplant rejection, building upon prior issued U.S. and EU patent for quantification of donor derived cfDNA, supporting the launch of TheraSure Transplant Monitor as an LDT in the U.S.

●Launched and completed site enrollment of the first Real-World Evidence (RWE) registry intended to evaluate biomarker adoption and precision medicine in creating personalized treatment options for early-stage lung cancer patients, with enrollment targeting more than 1,000 patients at 25 sites across the U.S. beginning in Q4 2021.

Corporate

·Appointed industry veteran Gisela A. Paulsen as Chief Operating Officer in October 2021.

Third Quarter 2021 Financial Results

On September 30, 2021, Oncocyte had cash, cash equivalents and marketable securities of $44.3 million, as compared to $7.8 million on December 31, 2020.

Oncocyte currently derives its revenues from the sale of its lung cancer test, DetermaRx, which was commercially launched in early 2020 and pharma services generated by its wholly owned subsidiary, Insight Genetics, which was acquired on January 31, 2020. During the first quarter of 2021, after accumulating additional history of cash receipts and other factors considered by management for Medicare Advantage-covered DetermaRx tests, including the recently published Medicare rate, the Company transitioned to the accrual basis for tests covered by Medicare Advantage insurance plans. Oncocyte will continue to recognize revenues for commercial and other payors on a cash basis until we have reimbursement contracts with those payors. At that point, those contracts will also progress to the accrual basis for DetermaRx tests. Until that time, for all payors other than Medicare and Medicare Advantage, Oncocyte expects to recognize revenue for DetermaRx tests performed on a cash basis.

Revenues for the three months ended September 30, 2021, were approximately $1.0 million, generated from three sources: DetermaRx tests, pharma services, and licensing revenues. This compares to revenues of $555,000 for the three months ended September 30, 2020, a year over year growth rate of 77%. DetermaRx samples received this quarter grew 3% compared to last quarter, primarily due to the impact of the Delta Variant on surgical volumes in key sales regions of the United States and 65% versus Q3 2020 .

Cost of revenues for the third quarter 2021 were approximately $1.9 million, which includes approximately $1.0 million in non-cash amortization expenses from the Razor Genomics and Insight Genetics acquisitions. The cost of our Razor asset amortization, which is a non-cash amortization expense over the remaining life of the Razor patent, will be included in cost of revenues each quarter. Cost of revenues also include testing services we perform for our pharma customers.

Research and development expenses for the third quarter of 2021 were $3.1 million as compared to $2.6 million for the same period in 2020, an increase of $0.5 million, representing the increased investment in clinical studies to support the commercialization of the portfolio of tests in the pipeline.

General and administrative expenses for the third quarter of 2021 were $5.5 million, as compared to $5.0 million for the same period in 2020, an increase of approximately $0.5 million.

Sales and marketing expenses for the three months ended September 30, 2021 were $2.9 million, as compared to $1.6 million for the same period in 2020. The increase was primarily due to personnel and related expenses resulting from the ramp up in sales and marketing activities for DetermaRx, as well as market development investments in preparation for the launch of new products later this year.

Operating losses, as reported, for the third quarter of 2021 were $13.6 million, as compared to $6.2 million for the third quarter of 2020. Operating losses, on an adjusted basis, were $9.3 million, an increase of $3.2 million from $6.1 million as compared to the third quarter of 2020.

Oncocyte has provided a reconciliation between GAAP and non-GAAP operating losses in the financial tables, included with this earnings release, which it believes is helpful in understanding its ongoing operations.

For the third quarter ended September 30, 2021, Oncocyte reported a net loss of $13.8 million, or ($0.15) per share, as compared to $6.8 million, or ($0.10) per share, for the third quarter ended September 30, 2020.

Cash used in operations was approximately $11.0 million for the third quarter of 2021.

Conference Call Information

The Company will host a conference call today, November 9th at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments. The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID: 13722620. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here View Source The webcast replay will be available on the Oncocyte website for 90 days following the completion of the call.

On November 9, 2021 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of dermatologic, autoimmune, and other debilitating diseases, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Vical, NOV 9, 2021, View Source [SID1234595211]).

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"This has been an exciting period for Brickell, as we announced positive data from our Phase 3 pivotal clinical studies of sofpironium bromide gel, 15% and expanded our pipeline with the acquisition of a Phase 1-ready DYRK1A inhibitor and cutting-edge platform with broad potential in autoimmune and inflammatory disorders. We look to build on this momentum by focusing on several near-term clinical, regulatory, and operational milestones that we believe can drive our growth," commented Robert Brown, Chief Executive Officer of Brickell. "We were pleased to announce last month that the Phase 3 Cardigan I and Cardigan II studies of sofpironium bromide gel, 15% in patients with primary axillary hyperhidrosis, or excessive underarm sweating, achieved statistical significance on all primary and secondary efficacy endpoints. Based on the positive results from these studies, we expect to submit an NDA for sofpironium bromide gel, 15% to the FDA in mid-2022. As we plan the commercial strategy for sofpironium bromide gel, 15%, if approved, we are evaluating all available options to maximize commercial product success and long-term value for the company."
"We look forward to advancing the development of our DYRK1A inhibitor programs that aim to restore immune balance with a novel and differentiated small molecule approach, which we believe will help improve the lives of patients with autoimmune diseases. To this end, we expect to advance our lead DYRK1A inhibitor program, BBI-02, into a Phase 1 clinical study in the first half of 2022, with topline results anticipated by the end of 2022. We look forward to providing updates on this planned study in the coming months," continued Mr. Brown.
Business and Recent Developments
•Reported positive topline results from two U.S. Phase 3 pivotal clinical studies of sofpironium bromide gel, 15%, each of which enrolled approximately 350 patients who were nine years of age and older with primary axillary hyperhidrosis. Both studies achieved statistical significance on all primary and secondary efficacy endpoints, and data demonstrated that sofpironium bromide gel, 15% was generally well-tolerated.
•Acquired exclusive, worldwide rights to research, develop, and commercialize novel therapeutics generated from a proprietary DYRK1A inhibitor platform with broad potential in autoimmune and inflammatory diseases. The acquisition includes BBI-02, a Phase 1-ready, highly selective, and orally bioavailable DYRK1A inhibitor; BBI-03, a topically applied preclinical DYRK1A inhibitor; and a platform of DYRK1A inhibitors with potential to create next-generation kinase inhibitors targeting neuroinflammatory and autoimmune disorders.
•Hosted a Key Opinion Leader ("KOL") webinar featuring a presentation by KOL Bernard Khor, M.D., Ph.D., Benaroya Research Institute at Virginia Mason, who discussed the latest findings on the novel target DYRK1A, its role in autoimmune and inflammatory diseases, and the broad therapeutic potential of restoring immune homeostasis by inhibiting DYRK1A. A replay of the event can be found on the Events and Presentations section of the Company’s website at View Source

•Expanded leadership team by appointing Dr. Monica Luchi as Chief Medical Officer to oversee the Company’s clinical development strategy, including for the DYRK1A inhibitor pipeline, and medical affairs functions.
•Brickell’s development partner, Kaken Pharmaceutical Co., Ltd. ("Kaken"), continued conduct of a Phase 1 clinical study in Japan assessing the pharmacokinetics (PK), safety, and efficacy of sofpironium bromide gel in patients with primary palmoplantar hyperhidrosis.
•Strengthened cash balance with net proceeds of $8.9 million received from a public offering of the Company’s common stock in October 2021.
Upcoming Milestones
•Prospective NDA submission to the U.S. FDA for sofpironium gel, 15% in mid-2022.
•Intend to progress BBI-02 into a Phase 1 clinical study in Canada in the first half of 2022, with topline results expected by the end of 2022.
•Expect to conduct formulation development activities for BBI-03 throughout 2022, and to select and initiate development of a lead next-generation candidate from the DYRK1A inhibitor platform with potential for the treatment of neuroinflammatory and/or autoimmune diseases.
Third Quarter 2021 Financial Results
The Company reported cash and cash equivalents of $21.4 million as of September 30, 2021, compared to $30.1 million as of December 31, 2020.
Revenue was $0.1 million for the third quarter of 2021, which consisted of royalty revenue recognized related to sales of ECCLOCK in Japan by Kaken. Revenue was $0.1 million for the third quarter of 2020, which was driven by collaboration revenue recognized for research and development funding provided by Kaken to Brickell in 2018.
Research and development expenses were $10.2 million for the third quarter of 2021, compared to $1.3 million for the third quarter of 2020. This increase was primarily due to a $4.8 million expense recorded related to the upfront payment in cash and shares of our common stock to Voronoi Inc. in exchange for exclusive, worldwide rights to the proprietary DYRK1A inhibitor platform and an increase of $3.8 million in clinical costs related to sofpironium bromide.
General and administrative expenses were $3.3 million for the third quarter of 2021, compared to $3.2 million for the third quarter of 2020, remaining generally consistent with the comparable period.
Brickell’s net loss was $13.3 million for the third quarter of 2021 compared to $4.3 million for the third quarter of 2020.
Conference Call and Webcast Information
Brickell’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13723603. A live webcast of the conference call can be accessed at View Source or through the Brickell Biotech website at View Source A replay will be available on this website shortly after conclusion of the event for approximately 90 days.
About Sofpironium Bromide
Sofpironium bromide is a new chemical entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action locally and are potentially rapidly metabolized into a less active form once absorbed into the blood. Brickell has developed sofpironium bromide gel, 15% as a potential best-in-class, self-administered, once daily, topical therapy for the treatment of primary axillary hyperhidrosis, also known as excessive underarm sweating. Sofpironium bromide gel, 15% has completed a U.S. Phase 3 pivotal clinical program for the treatment of primary axillary hyperhidrosis, which achieved statistical significance on all primary and secondary efficacy endpoints, and sofpironium bromide gel, 15% was generally well-tolerated. Sofpironium bromide gel, 5% is approved in Japan for the same indication

under the brand name ECCLOCK. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida.
About the DYRK1A Inhibitor Platform
In August 2021, Brickell acquired exclusive, worldwide rights to research, develop, and commercialize novel therapeutics generated from a proprietary DYRK1A inhibitor platform. These novel DYRK1A inhibitors aim to restore immune balance in patients whose immune system has become dysregulated. Based on the promising preclinical efficacy data generated to date on these novel DYRK1A inhibitor programs, Brickell believes this platform has the potential to offer first-in-class, new and potent therapies across a wide array of autoimmune and inflammatory diseases. The initial lead program that the Company expects to advance is BBI-02, a Phase 1-ready, highly selective, and orally bioavailable DYRK1A inhibitor that has demonstrated promising results in various preclinical models, including atopic dermatitis and rheumatoid arthritis. Preclinical data have shown BBI-02 to drive regulatory T-cell differentiation while dampening pro-inflammatory TH17 cells and MyD88/IRAK4-related signaling pathways. Unlike many existing therapies, as well as those currently being investigated, BBI-02 may have the ability to target both the adaptive and innate immune imbalance simultaneously, potentially resulting in, or substantially achieving, restoration of immune homeostasis that, if proven, would represent a paradigm shift in the treatment of certain autoimmune and inflammatory diseases. The platform also includes BBI-03, a topically applied preclinical DYRK1A inhibitor, and has the potential to create next generation kinase inhibitors (NCEs) targeting neuroinflammatory and autoimmune disorders.