On March 9, 2023 Teva Pharmaceutical Finance Netherlands II B.V. ("Teva Finance II"), a wholly owned subsidiary of Teva Pharmaceutical Industries Limited (the "Company"), issued €800,000,000 aggregate principal amount of 7.375% Sustainability-Linked Senior Notes due 2029 (the "2029 Euro Notes") and €500,000,000 aggregate principal amount of 7.875% Sustainability-Linked Senior Notes due 2031 (the "2031 Euro Notes" and, together with the 2029 Euro Notes, the "Euro Notes"); and (ii) Teva Pharmaceutical Finance Netherlands III B.V. ("Teva Finance III" and, together with Teva Finance II, the "Issuers"), a wholly owned subsidiary of the Company, issued $600,000,0000 aggregate principal amount of 7.875% Sustainability-Linked Senior Notes due 2029 (the "2029 USD Notes") and $500,000,000 aggregate principal amount of 8.125% Sustainability-Linked Senior Notes due 2031 (the "2031 USD Notes" and, together with 2029 USD Notes, the "USD Notes" and together with the Euro Notes, the "Notes") (Filing, 8-K, Teva, MAR 9, 2023, View Source [SID1234628444]).

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Teva intends to use the net proceeds from the Notes (i) to fund the announced tender offer for a maximum combined aggregate purchase price (exclusive of accrued and unpaid interest) of up to $2,500,000,000 (equivalent) (upsized from a previously announced cap of $2,250,000,000), (ii) to pay fees and expenses in connection therewith, and (iii) to the extent of any remaining proceeds, for the repayment of outstanding debt upon maturity, tender offer or earlier redemption. Net proceeds may be temporarily invested pending application for their stated purpose.

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 Fourth Supplemental Indenture, dated as of March 9, 2023 (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 Fourth Supplemental Indenture, dated as of March 9, 2023 (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 March 15 and September 15 of each year, beginning on September 15, 2023, until their maturity dates of September 15, 2029 for the 2029 Euro Notes and the 2029 USD Notes and September 15, 2031 for the 2031 USD Notes and the 2031 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 September 15, 2026 (the "Step-up Date"), the interest rate payable on the Notes shall increase by:

(a) 0.100% 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) 0.100% 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) 0.100% 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);

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. 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 2029 Euro Notes at any time on or after June 15, 2029 (three months prior to the maturity date of the 2029 Euro Notes) or to redeem the 2031 Euro Notes at any time on or after June 15, 2031 (three months prior to the maturity date of the 2031 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. 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, 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 2029 USD Notes at any time on or after June 15, 2029 (three months prior to the maturity date of the 2029 USD Notes) or to redeem the 2031 USD Notes at any time on or after June 15, 2031 (three months prior to the maturity date of the 2031 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 February 27, 2023, and filed with the Commission on February 27, 2023 pursuant to Rule 424(b)(3) promulgated under the Securities Act and the free writing prospectus related thereto, dated March 1, 2023, and filed with the Commission on March 1, 2023 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 2029 Euro Notes, the form of 2031 Euro Notes, the USD Notes Base Indenture, the USD Notes Supplemental Indenture, the form of 2029 USD Notes and the form of 2031 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 March 9, 2023 Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported financial results for the fourth quarter and full-year ended December 31, 2022, and provided a strategic update (Press release, Olema Oncology, MAR 9, 2023, View Source [SID1234628443]).

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"2022 was a successful year for Olema as we generated important clinical data advancing the opportunity for OP-1250, our complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD), as both a monotherapy and in combination with a CDK4/6 inhibitor. We continue to have confidence in OP-1250’s ability to become a best-in-class treatment option for ER+/HER2- metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We are committed to realizing the full potential of OP-1250, which we believe has demonstrated a clear, differentiated advantage as a complete ER antagonist and the potential endocrine therapy of choice. Given the challenging equity market environment, we made some difficult decisions regarding our organization and earlier-stage programs. As we sharpen our focus on the late-stage clinical development of OP-1250, we remain steadfast in our goal of bringing this potentially transformative therapy to women living with breast cancer."

Olema’s restructuring announced today is the result of a strategic decision to focus resources on the late-stage clinical development of OP-1250, which includes the initiation of the company’s first pivotal Phase 3 trial in the second half of this year. As a result of the restructuring, Olema’s workforce will be reduced by approximately 25%, affecting employees across research, early development, and general and administrative functions. Chief Business Officer Kinney Horn will be departing the company, and Cyrus Harmon, Ph.D., co-founder of Olema, will step down from his role as the Chief Research Officer and remain a member of Olema’s Board of Directors.

"I am grateful to our employees for their strong commitment to our mission and dedication to patients. I would like to thank Kinney for his important contributions to Olema since joining in 2020, and we wish him well in his future endeavors," continued Dr. Bohen. "Cyrus, who is a co-founder of Olema, has been an inspirational leader and was instrumental in the discovery and early development of OP-1250. His continued guidance as a member of the Board will be vital as we progress OP-1250 though late-stage development."

2022 Corporate Highlights

● Presented clinical results from a Phase 1/2 clinical study of OP-1250 at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2022), which demonstrated that, across 68 heavily pre-treated patients, OP-1250 was well tolerated with attractive pharmacokinetics and sustained drug exposure levels approximately 20 times that of fulvestrant at the 120 mg daily dose. In addition, OP-1250 demonstrated strong anti-tumor activity, with 41% of patients seeing reductions in target tumor lesions, and durable benefit with a 39% clinical benefit rate (CBR) at the 120 mg dose level on a maturing dataset. Six partial responses (four confirmed and two unconfirmed) were observed in 57 efficacy-evaluable patients.
● Presented clinical results from a Phase 1b combination study at the 2022 San Antonio Breast Cancer Symposium (SABCS), which demonstrated OP-1250’s combinability with palbociclib with a tolerability profile consistent with palbociclib in combination with an aromatase inhibitor or fulvestrant, no drug-drug interaction, and no induced metabolism of palbociclib.
● Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for OP-1250 for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor.
● Initiated a Phase 1b combination study with CDK4/6 inhibitor, ribociclib, and phosphoinositide 3-kinase alpha (PI3Ka) inhibitor, alpelisib.
● Announced an exclusive global license agreement with Aurigene Discovery Technologies Limited (Aurigene) to research, develop and commercialize novel small molecule inhibitors of an undisclosed oncology target.
Anticipated Upcoming Milestones

● Initiate a pivotal Phase 3 monotherapy clinical trial in the second- and third-line setting of ER+/HER2- advanced or metastatic breast cancer in the second half of 2023.
● Present Phase 2 combination with CDK4/6 inhibitor (palbociclib) clinical study results in the second quarter of 2023.
● Present Phase 2 monotherapy clinical study results in the second half of 2023.
● Present Phase 1b combination with CDK4/6 inhibitor (ribociclib) clinical study results in the second half of 2023.

Fourth Quarter and Full-Year 2022 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2022, were $204.4 million. Olema anticipates that this balance will be sufficient to fund operations into 2025.

Net loss was $26.2 million and $104.8 million for the quarter and year ended December 31, 2022, respectively, as compared to $21.6 million and $71.1 million for the quarter and year ended December 31, 2021, respectively. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development activities including an $8.0 million upfront payment to Aurigene in the second quarter, and an increase in general and administrative (G&A) costs.

GAAP research and development (R&D) expenses were $21.6 million and $82.3 million for the quarter and year ended December 31, 2022, respectively, as compared to $16.0 million and $51.1 million for the quarter and year ended December 31, 2021, respectively. The increase in R&D expenses was primarily related to increases in advancing ongoing clinical studies of OP-1250 and associated manufacturing costs, nonclinical research and discovery program activities, including an $8.0 million upfront payment to Aurigene in the second quarter, and personnel-related expenses due to higher headcount, including non-cash stock-based compensation expenses.

Non-GAAP R&D expenses were $18.2 million and $69.8 million for the quarter and year ended December 31, 2022, respectively, excluding $3.4 million and $12.5 million non-cash stock-based compensation expense, respectively. Non-GAAP R&D expenses were $13.1 million and $41.8 million for the quarter and year ended December 31, 2021, respectively, excluding $2.9 million and $9.3 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $5.6 million and $24.7 million for the quarter and year ended December 31, 2022, respectively, as compared to $5.8 million and $20.4 million for the quarter and year ended December 31, 2021, respectively. The increase in G&A expenses was primarily related to increases in personnel-related expenses due to higher headcount, including non-cash stock-based compensation expense, and public company-related expenses, including legal compliance and other corporate costs.

Non-GAAP G&A expenses were $4.1 million and $18.3 million for the quarter and year ended December 31, 2022, respectively, excluding $1.5 million and $6.4 million non-cash stock-based compensation expense respectively. Non-GAAP G&A expenses were $4.1 million and $13.8 million for the quarter and year ended December 31, 2021, excluding $1.7 million and $6.6 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

On March 9, 2023 Ad hoc announcement pursuant to Art. 53 LR: Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built proteins known as DARPin therapeutics, reported its corporate highlights and audited financial results for the full year 2022 (Press release, Molecular Partners, MAR 9, 2023, View Source [SID1234628441]).

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"Our focus in 2023 is the advancement of highly differentiated DARPin therapeutic candidates with the potential to show early clinical value. Recently we dosed the first patient with MP0533, our novel tri-specific T-cell engager for the treatment of AML and high risk MDS. We also announced a breakthrough with our Radio DARPin Therapy Platform which enables us to reduce dose-limiting kidney uptake and potentially opens the door for a pipeline of new candidates, of which the first is targeting Delta-like ligand 3 (DLL3). MP0317, our localized CD40 agonist, has reached its top planned dose without limiting side effects, showing a clear differential against conventional systemically active agonists," said Patrick Amstutz, Ph.D. Molecular Partners’ Chief Executive Officer. "With our ongoing strong cash position, we will continue to advance our DARPin candidates to deliver on our mission to develop solutions only DARPin therapies can offer to patients living with serious diseases."

Research & Development Highlights

Oncology

MP0317
In November 2022, Molecular Partners presented interim results from the ongoing Phase 1 trial of MP0317, the Company’s DARPin candidate targeting fibroblast activation protein (FAP) and CD40, for the treatment of solid tumors at the 37th SITC (Free SITC Whitepaper) Annual meeting. These data demonstrated the first clinical observation of tumor-localized CD40 activation provided by MP0317. The candidate was also seen to be safe and well tolerated with no dose-limiting CD40-related systemic toxicities to date, a key limitation presented by other CD40 agonists. MP0317 is designed to resolve these limitations by activating immune cells specifically within the tumor microenvironment through the simultaneous binding of the immune stimulator CD40 as well as FAP, a protein highly expressed within tumors. The dose escalation of the Phase 1 study remains ongoing, with patient recruitment in the dose escalation portion of the of the Phase 1 trial of MP0317 expected to be completed in the first half of 2023.

MP0533
In January 2023, the first patient was dosed in Molecular Partners’ Phase 1 study of MP0533, a novel tri-specific T-cell engager for the treatment of AML and high risk MDS. The first clinical results from this trial are expected by the fourth quarter of 2023. In an oral presentation at the 64th Annual ASH (Free ASH Whitepaper) Meeting in December 2022, Molecular Partners presented preclinical results showing MP0533 can induce preferential killing of cells expressing two or three tumor-associated antigens (TAAs) compared to cells expressing a single TAA. MP0533 engages CD3 on T-cells while binding up to three tumor-associated antigens (CD33, CD70, and CD123) on AML cells. By modulating the affinity to each TAA, Molecular Partners designed MP0533 to induce T-cell-mediated killing preferentially when the cancer cells express two or three of the TAAs. This avidity-driven T-cell activation ensures preferential killing of AML cells, which consistently express two or three of the target antigens. At the same time, it is designed to reduce the damage to healthy cells, which tend to express only one of the target antigens, a recurrent issue with other T-cell engagers in AML. MP0533 was demonstrated to activate T-cells and destroy AML cells in samples from newly diagnosed and previously treated AML patients with different TAA expressions. Humanized mouse models confirmed MP0533’s ability to activate intra-tumoral T-cells and control tumor growth. The research also showed that MP0533 was able to directly target and kill leukemic stem cells (LSCs), while sparing a variety of healthy cells including hematopoietic stem cells. The unique safety profile of MP0533 was further supported preclinically by several other parameters including a lower level of cytokine release relative to benchmark mono-targeted T-cell engagers, both in vitro in a whole blood assay and in vivo in the humanized mouse AML models.

Radio DARPin Therapy Platform
In 2022, Molecular Partners progressed its Radio DARPin Therapy Platform by reducing the kidney uptake of DARPin radio conjugates to overcome nephrotoxicity (toxicity in the kidney), the key limitation of protein-based radio therapies. Furthermore, tumor-associated protein Delta-like ligand 3 (DLL3) was selected as the first target of a DARPin-based therapeutic candidate. Expression of DLL3 is low in healthy tissue but significantly increased in certain tumor types, providing an opportunity for selective targeting through the high affinity and specificity offered by DARPins. These attributes, along with their small size, suggest that DARPins represent ideal delivery vectors for therapeutic radionuclides to efficiently target cancer cells with minimal systemic side effects. Molecular Partners is developing DARPin-based therapeutic candidates, both proprietary as well as in collaboration with Novartis. The Company plans to present its research of DARPin therapeutic candidates and their potential differentiation as tumor targeting moieties in the first half of 2023.

Virology

An Emergency Use Authorization (EUA) application was submitted to the U.S. Food and Drug Administration on February 4, 2022 following the successful global EMPATHY clinical study which demonstrated the efficacy and safety of ensovibep, the first DARPin-based antiviral molecule. Ensovibep also demonstrated in vitro efficacy against most Variants of Concern relative to some antibody therapies, a characteristic Molecular Partners intends to continue leveraging in further antiviral candidates. The clinical development of ensovibep was halted in 2022 due to a lack of neutralization activity against omicron subvariants.

Earlier this year, Novartis informed Molecular Partners that it had submitted a request to withdraw ensovibep’s EUA from the FDA. The EUA application for ensovibep was withdrawn effective January 25, 2023.

Looking ahead for the virology portfolio, in January 2023 Molecular Partners signed a non-binding letter of intent with Novartis to negotiate a Research Framework Agreement with a primary focus on establishing pandemic preparedness and fighting emerging infectious global health threats.

Ophthalmology

In November 2021, Molecular Partners regained global development and commercial rights to abicipar for the treatment of neovascular age-related macular degeneration (nAMD) and Diabetic Macular Edema (DME). Abicipar completed two positive Phase 3 studies, CEDAR and SEQUOIA, which supported the non-inferior efficacy of its quarterly dosing regimen compared to monthly ranibizumab.

The Company continues to evaluate potential business opportunities for abicipar outside of internal development at Molecular Partners.

Corporate Governance and Leadership Highlights

Chief Executive Officer Patrick Amstutz was elected as President of the Swiss Biotech Association Board of Directors effective May 3, 2022. Switzerland has become one of the global hubs for life sciences and this position will allow Patrick the opportunity to provide leadership and influence in the biopharma industry both regionally and globally.

Alexander Zürcher was promoted to Chief Operating Officer, effective July 1, 2022. Coinciding with Alexander’s promotion, Michael Stumpp, the Company’s prior COO, transitioned to the newly formed position of EVP Projects while remaining a member of the Company’s Management Board. Renate Gloggner was promoted to EVP People and Community, effective as of July 1, 2022. Both Alexander and Renate were appointed to the Company’s Management Board, also effective as of July 1, 2022.

Michael Pitzner appointed General Counsel and Senior Vice President of Legal effective November 1, 2022. Most recently Michael served as Head Legal Biologics, Cell & Gene and CMO (Global NTO) at Novartis.

Anne Goubier, D.V.M, Ph.D., was promoted to Senior Vice President of Biology. Anne joined Molecular Partners in 2020 and oversees the biology department, overseeing development from target identification to clinical pharmacology, building on her more than two decades of biotechnology experience across drug discovery and development.

CFO Andreas Emmenegger departed the company as of Dec. 31, 2022 following a successful tenure of more than 15 years. His successor will be announced in due course and we are committed to a smooth transition.

ESG initiatives

In 2022, Molecular Partners published its environmental, social and governance (ESG) priorities and progress, accessible on the investors section of its website. Currently, the Company is creating a baseline status evaluation as the next step toward implementing an ESG plan with clear metrics that detail its progress across priority areas: board oversight of ESG and corporate sustainability; human capital management and Diversity, Equity and Inclusion (DEI); product service and safety; access to medicine; and business ethics.

In its continued commitment to corporate sustainability, Molecular Partners advanced its ESG goal by formally establishing corporate sustainability responsibility at a Board level. The Finance and Audit Committee will lead oversight of all ESG policies for the Board. To fully integrate the Company’s ESG strategy within the organization, Molecular Partners has created an ESG Circle of key internal stakeholders to ensure continued progress is made across key priorities. Elsewhere, Molecular Partners offers generous benefits spanning from health to retirement planning to its employees, and fosters diversity and inclusion as a key element of its recruitment process.

2022 Operational and Financial Highlights

Following Novartis’ payment of CHF 150 million for ensovibep in January 2022, Molecular Partners remains well funded to capture upcoming value inflection points in 2023 and beyond. In the financial year 2022, Molecular Partners recognized total revenues and other income of CHF 189.6 million (2021: CHF 9.8 million) and incurred total expenses of CHF 73.0 million (2021: CHF 73.2 million). This led to an operating profit of CHF 116.6 million for 2022 (2021: Operating loss of CHF 63.4 million). The net financial gain recorded in 2022 was CHF 1.2 million, compared to a net financial loss of CHF 0.4 million in 2021. This resulted in a 2022 net profit of CHF 117.8 million (2021: Net loss of CHF 63.8 million).

The net cash from operating activities in 2022 was CHF 118.6 million (2021: Net cash used of CHF 91.0 million). Including short-term time deposits, the cash and cash equivalents position increased by CHF 116.3 million as compared to year-end 2021, to CHF 249.1 million as of December 31, 2022 (December 31, 2021: CHF 132.8 million). Total shareholders’ equity stood at CHF 235.2 million as of December 31, 2022, an increase of CHF 127.9 million (December 31, 2021: CHF 107.3 million).

The Company’s cash position and short-term time deposits of total CHF 249.1 million as per December 31, 2022, continues to provide the Company with financial flexibility and a forecasted cash runway into 2026.

The Company’s balance sheet continued to be debt-free in 2022. As of December 31, 2022, the Company employed 175.3 FTE (full-time equivalents), up 7% year-on-year. About 81% of the employees are employed in R&D-related functions.

Key figures as of December 31, 2022

Key Financials (CHF million, except per share, FTE data) FY 2022 FY 2021 Change
Total revenues and other income 189.6 9.8 179.8
R&D expenses (50.7 ) (55.7 ) 5.0
SG&A expenses (22.3 ) (17.5 ) (4.8 )
Operating result 116.6 (63.4 ) 180.0
Net finance result 1.2 (0.4 ) 1.6
Net result 117.8 (63.8 ) 181.6
Basic net result per share (in CHF) 3.63 (2.06 ) 5.69
Diluted net result per share (in CHF) 3.54 (2.06 ) 5.60
Net cash from (used in) operating activities 118.6 (91.0 ) 209.5
Cash & cash equivalents (incl. short-term time deposits) 249.1 132.8 116.3
Total shareholders’ equity 235.2 107.3 127.9
Number of total FTE 175.3 163.2 12.1

Business outlook and priorities

In 2023, the Company will continue to invest in its clinical stage assets as well as in its development portfolio, particularly in the areas of Radio DARPin therapeutics, oncology, and virology. With initial data from the phase 1 study of MP0533 expected before the end of the year, the potential to further integrate this program as a later stage, wholly-owned asset remains strong. The conclusion of recruitment in the phase 1 study of MP0317 will provide an opportunity to discuss additional combination work with potential collaborators.

As we continue to detail our work in Radio DARPins with presentations at scientific congresses throughout the year, we aim to demonstrate that DARPins can serve as high-affinity tumor targeting therapeutics while providing a high level of kidney protection, a common limiting toxicity associated with other radio therapies. In addition, we continue to remain excited about the prospect of DARPins in virology, within the potential of our own pipeline and with our newly announced letter of intent with Novartis to explore the potential of DARPins in emerging global health threats.

Financial outlook 2023

For the full year 2023, at constant exchange rates, the Company expects total operating expenses of CHF 70-80 million, of which around CHF 9 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation.

Based on the Company’s cash position as of December 31, 2022, the Company expects its cash runway to reach into 2026, excluding any potential receipts from R&D partners.

Documentation

This press release, the Company’s Annual Report on Form 20-F for the year ended December 31, 2022 to be filed with the U.S. Securities and Exchange Commission (SEC), and the Company’s annual report 2022 will be made available through www.molecularpartners.com under the investor section after 22.00 CET (16.00 EST) on March 9, 2023.

Full year 2022 conference call & audio webcast

Molecular Partners will hold a conference call and audio webcast on March 10, 14.00 CET (8.00 am EST).
To register for the full year 2022 conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:

Switzerland / Europe +41 800 83 6507
USA +1 844 865 3856
Full list of dial-in numbers linked here

Conference ID Please ask to be joined into the Molecular Partners call.

Participants in the conference call will have the opportunity to ask questions after the presentation.

Audio webcast

The full year 2022 results will be webcast live and will be made available on the Company’s website under the investor section. The replay will be available for 90 days following the presentation.

Financial calendar

April 4, 2023 Annual General Meeting
May 11, 2023 Interim Management Statement Q1 2023
August 24, 2023 Half-year results 2023 (unaudited)
October 26, 2023 Interim Management Statement Q3 2023
The latest timing of the above events can always be viewed on the investor section of the website.

On March 9, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported financial results for the fourth quarter and full year ended December 31, 2022, and provided recent clinical and corporate updates (Press release, Gritstone Bio, MAR 9, 2023, View Source [SID1234628439]).

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"In 2022, we presented positive Phase 1 or 2 data across our GRANITE, SLATE and CORAL vaccine programs, highlighting our ability to generate potent and durable immune responses in both cancer and infectious diseases," said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. "Of greatest potential importance within our cancer vaccine programs, GRANITE and SLATE, is the consistent association between vaccine-elicited molecular responses in patients with prolonged overall survival. Also of note, we have demonstrated the ability of our therapies to turn "cold" tumors into "hot" ones – even in tough settings such as third line MSS-CRC. The positive results seen in these studies in treatment-refractory disease, coupled with consistent generation of neoantigen-specific cytotoxic T cells, underline the potential of our antigen prediction and heterologous prime-boost vectors (adenovirus and samRNA) to drive clinically important and differentiated immune responses. The clear next step is to move upstream and test the approach in newly diagnosed metastatic cancer patients, and this is well underway in a randomized Phase 2/3 trial with GRANITE in MSS-CRC."

Dr. Allen continued, "In 2023, we have several important milestones, most notably, the preliminary Phase 2 data from our Phase 2/3 GRANITE study in frontline MSS-CRC by year-end. We also plan to initiate a new, randomized Phase 2 trial of a KRAS-directed SLATE in patients with newly-diagnosed metastatic cancer in the second half of the year. We are highly encouraged by the data from our GRANITE program to date and believe success with our Phase 2/3 GRANITE study would support expanded evaluation across both cold and hot tumors and into different treatment settings including adjuvant therapy. This is an important year for personalized cancer vaccines, with multiple companies reporting randomized trial data, and a positive outcome in our trial in metastatic CRC, a clearly "cold" tumor, would be of huge significance, potentially opening the door for the majority of solid tumor patients to derive benefit from immunotherapy for the first time. Fueled by the extended survival and promising patient outcomes observed in our Phase 1/2 in advanced CRC, which are published in Nature Medicine, we confidently await our randomized Phase 2 data late this year."

Clinical Program Updates
Tumor-Specific Neoantigen (TSNA) Oncology Programs
GRANITE – Individualized, TSNA-directed vaccine-based immunotherapy
SLATE – "Off-the-shelf" shared TSNA-directed vaccine-based immunotherapy

Preliminary data from the randomized Phase 2/3 study evaluating GRANITE (individualized neoantigen vaccine for microsatellite-stable colorectal cancer [MSS-CRC]) remain expected in 4Q 2023.
— Enrollment of the Phase 2 portion of study, designed to evaluate the individualized neoantigen vaccine as a maintenance therapy in eighty patients with first-line MSS-CRC, is ongoing.

— The company remains on track to report preliminary data from the Phase 2 portion of the study, molecular response (circulating tumor DNA [ctDNA]) and progression-free survival data [evaluated by both RECIST and iRECIST criteria] on patients completing at least 4 months of treatment, in 4Q 2023.

Positive results from Phase 1/2 studies of GRANITE and SLATE reinforce association between molecular response (reduction in ctDNA level) and extended overall survival.

GRANITE
— In August 2022, interim results from the Phase 1/2 trial of GRANITE, Gritstone’s individualized neoantigen vaccine for solid tumor cancers, were published in Nature Medicine (here). The paper describes how Gritstone’s neoantigen-directed dual vaccination approach (referred to as "prime-boost") led to both priming and boosting of tumor-specific cytotoxic T cells, with associated molecular responses in approximately half of treated advanced colorectal cancer (CRC) patients.

— In November 2022, Gritstone announced the median overall survival (mOS) among molecular responders living with third line MSS-CRC (a subset within the Phase 1/2 study of GRANITE) will exceed 22 months; median not yet reached (here). This compares to mOS of 7.8 months in evaluable MSS-CRC patients in the study who did not exhibit a molecular response, and mOS of 6-7 months observed in pivotal studies of FDA-approved therapeutics in this context (trifluridine/tipiracil combination and regorafenib monotherapy). Molecular response rate (MRR) among evaluable MSS-CRC patients was 55% (6/11).

SLATE
— In September 2022, initial results shared at ESMO (Free ESMO Whitepaper) from Phase 1/2 study of KRAS-directed SLATE demonstrated similar molecular response rate and overall survival trend (here). In 38 patients with advanced solid tumors (largely MSS-CRC and NSCLC), SLATE v1 (n =26) and SLATE-KRAS (n=12) demonstrated a 39% MRR in evaluable patients with MSS-CRC and NSCLC. In 18 patients with NSCLC, all of whom had progress on prior (chemo)immunotherapy, a molecular response was correlated with extended OS. NSCLC patients with a molecular response demonstrated a median OS (9.6 months) more than double of those without a molecular response (4.5 months).
Infectious Disease Programs
CORAL – Second-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s infectious disease approach and the potential application of samRNA in infectious diseases.

Phase 1 CORAL studies continue, with enrollment in CORAL-CEPI trial (n = 341) now complete. Additional data from the CORAL-BOOST and CORAL-CEPI trials, which aim to further characterize and demonstrate the potential utility of self-amplifying mRNA (samRNA), are expected in 2Q2023.
— In August 2022, Gritstone reported 6-month neutralizing antibody data from the first two cohorts of its CORAL-BOOST trial. Results showed in all observable patients, the strong neutralizing antibody responses originally reported in January 2022 persisted without decay after 6 months (here).

— In October 2022, Gritstone shared interim positive results from the ongoing Phase 1 CORAL-BOOST and CORAL-CEPI studies at a Company-sponsored webinar. Collectively, these results showed Gritstone’s samRNA vaccine candidates to be well-tolerated and capable of driving strong, potentially durable and broad immunogenicity across several subject populations and settings.

— Enrollment in the CORAL-NIH trial completed in 2022. This study is sponsored and executed by the National Institute of Allergy and Infectious Disease (NIAID).
HIV – Collaboration with Gilead Sciences, Inc. (Gilead) under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment.

The collaboration with Gilead Sciences, Inc. (Gilead) to research and develop a vaccine-based HIV immunotherapy treatment remains active and ongoing.
Recent Corporate Updates

In October 2022, Gritstone raised $45 million through a private investment in public equity financing to support development of its ongoing and future pre-clinical and clinical programs.

In February 2023, Gritstone announced a clinical trial agreement with the National Cancer Institute (NCI) to evaluate an autologous T cell therapy expressing a T cell receptor targeting mutated KRAS in combination with Gritstone’s KRAS-directed vaccine candidate, SLATE-KRAS, in a Phase 1 study led by Steven A. Rosenberg, M.D., Ph.D.

In February 2023, results from a preclinical study conducted in collaboration with Gilead Sciences were presented at Conference on Retroviruses and Opportunistic Infections (CROI) 2023. The first data disclosed from the Gritstone-Gilead HIV Cure collaboration, results showed that simian immunodeficiency virus (SIV) Chimpanzee Adenovirus (ChAd) and self-amplifying mRNA (samRNA) vaccines induced a strong and broad CD8+ T cell immune response, which was significantly enhanced in combination with immune modulators.
Intellectual Property Update
Gritstone’s IP estate includes issued patents related to its processes and technologies, including Gritstone EDGE, the company’s novel epitope discovery platform used in neoantigen prediction for its personalized cancer vaccines.

In December 2022, Gritstone announced the United States Patent and Trademark Office (USPTO) issued two new patents related to the company’s novel self-amplifying mRNA (samRNA) vaccine platform technology (U.S. Patent No. 11,504,421 and U.S. Patent No. 11,510,973).

In February 2023, the USPTO issued a separate patent (U.S. Patent No. 11,264,117) directed to Gritstone’s proprietary ChAd vector, which is modified to improve viral production.
Full Year 2022 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $185.2 million as of December 31, 2022, compared to $223.5 million as of December 31, 2021.

Research and development expenses were $111.4 million for the year ended December 31, 2022 compared to $97.5 million for the year ended December 31, 2021. The increase was primarily due to increases in personnel-related costs and clinical trial expenses.

General and administrative expenses were $29.0 million for the year ended December 31, 2022 compared to $25.9 million for the year ended December 31, 2021. The increase was primarily attributable to an increase in personnel-related costs and an increase in outside services for legal, finance, recruiting and other professional services to support our ongoing operations.

Collaboration, license, and grant revenues were $19.9 million for the year ended December 31, 2022, compared to $48.2 million for the prior year. During the year ended December 31, 2022, we recorded $1.6 million in collaboration revenue related to the Gilead Collaboration Agreement, and $7.7 million in collaboration revenue related to the 2seventy bio Agreement. During the year ended December 31, 2022, we recorded $9.5 million in grant revenue related to the CEPI Agreement and $1.2 million in grant revenue related to the Gates Agreement.
Conference Call and Webcast Details
A conference call and webcast to discuss fourth quarter and full year 2022 results will be held at 4:30pm ET today (March 9):

Conference call: 1-877-407-4018
Conference ID: 13734754
Webcast: View Source;tp_key=44c4441022

An archived replay will be accessible at View Source for 30 days following the event.

On March 9, 2023 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that it will host a conference call and live audio webcast on Thursday, March 16, 2023 at 4:30 p.m. Eastern Time to discuss financial results for the fourth quarter and year ended December 31, 2022 and to provide a business update (Press release, CymaBay Therapeutics, MAR 9, 2023, View Source [SID1234628438]).

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Conference Call Details
To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID # 13736281. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source