On August 15, 2022 ADC Therapeutics SA (NYSE: ADCT) reported that it has completed a series of strategic transactions in which it (Press release, ADC Therapeutics, AUG 15, 2022, View Source [SID1234618384]):

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Entered into a new $175 million senior secured term loan with certain funds of Owl Rock, a division of Blue Owl Capital, Inc. ("Owl Rock"), and funds managed by Oaktree Capital Management, L.P. ("Oaktree") with an upfront tranche of $120 million received upon closing today;
Settled in full the $115 million aggregate principal amount of senior secured convertible notes held by Deerfield Management Company ("Deerfield") due May 2025 for (i) $117.3 million in cash including the contractual exit fee on principal repayment, (ii) 2,390,297 common shares approximately equal to the value of the remaining interest due on the convertible debenture to the end of term, and (iii) warrants to purchase an aggregate of 4,412,840 common shares at exercise prices of $24.70 and $28.07 per share;
Entered into a share purchase agreement with certain funds of Owl Rock, a division of Blue Owl Capital Inc., for an investment of $6.25 million for 733,568 common shares.
"We are pleased to enter into this agreement with Owl Rock and Oaktree, the proceeds of which will be used to pay the cash consideration in the exchange of the secured convertible credit notes held by Deerfield," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This new debt facility has a term of seven years and enables us to continue maximizing the potential of ZYNLONTA and advancing our pipeline of novel antibody drug conjugates for hematologic malignancies and solid tumors. The continued equity support of Deerfield and the additional equity support from Owl Rock is also very positive, and we are pleased to maintain our cash runway into early 2025 as this deal is approximately cash neutral during that timeframe."

Pursuant to the loan and guaranty agreement, the Company completed an initial drawdown of $120 million on August 15, 2022. This amount was used by the Company to fund the cash consideration as part of the settlement of Deerfield’s senior secured convertible notes. Up to two additional tranches in the amount of $27.5 million each can be drawn by the Company upon meeting certain conditions within 18 months. The term loan matures on August 15, 2029 and accrues interest at an annual rate of secured overall financing rate (SOFR) plus 7.50% or a base rate plus 6.50% for the first five years of the term loans and at an annual rate of SOFR plus 9.25% or a base rate plus 8.25% thereafter. In addition, the Company issued to the lenders under the term loan warrants to purchase an aggregate number of common shares equal to $4.375 million divided by the volume weighted-average price of the common shares for the ten trading days prior to their issuance and the ten trading days on and after their issuance, which warrants are exercisable for ten years from their issuance.

Owl Rock also agreed to purchase 733,568 common shares for $8.52 per share, which represents the 5-day volume-weighted average price as of Friday, August 12, 2022. The transaction is expected to close upon registration of the necessary share capital increase with the commercial register in Switzerland.

Sandip Agarwala, Managing Director with Owl Rock commented, "This transaction displays our ability to integrate our life sciences sector expertise and tailored multi-security approach to help provide growth capital to companies like ADC Therapeutics. We are pleased to invest in ADC Therapeutics’ strong team, portfolio and track record of success in developing and commercializing life-saving cancer therapies including ZYNLONTA."

"We are excited to partner with ADC Therapeutics as it continues to develop a pipeline of novel ADCs for hematologic malignancies and solid tumors," said Aman Kumar, Co-Portfolio Manager of Life Sciences Lending at Oaktree. "This is an important time in the Company’s development with its first product approval validating its first-in-class ADC platform. This commitment of capital represents our belief in the long-term potential of ADC Therapeutics and we look forward to working with the Company’s leadership team during this next phase of growth."

Elise Wang, Partner, Head of Private Equity Capital Markets at Deerfield said: "We have been a supporter of ADC Therapeutics dating back to its successful IPO in May 2020 as both an equity investor in the IPO and also providing the convertible debenture that is being retired today. We are very pleased to take a significant portion of the repayment consideration in ADCT stock and look forward to continuing to support the company going forward."

The transactions described herein are further described in a Report on Form 6-K filed today with the Securities and Exchange Commission. The descriptions herein are qualified in their entirety by reference to the further descriptions included in the Report on Form 6-K.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Morgan Stanley & Co. LLC acted as the sole placement agent to ADC Therapeutics on this transaction.

On August 15, 2022 Guardant Health Inc. (Nasdaq: GH), a leading precision oncology company, reported that Guardant Reveal, the only tissue-free test for the detection of residual and recurrent disease for colorectal cancer (CRC), is now available for patients with breast and lung cancers (Press release, Guardant Health, AUG 15, 2022, View Source [SID1234618382]).

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The Guardant Reveal blood test improves the management of early-stage cancer patients by detecting circulating tumor DNA (ctDNA) in blood after surgery—without the need for a tissue biopsy—to identify patients with minimal residual disease (MRD) who have a higher risk for recurrence and may benefit from additional therapy. The test has also been shown to predict disease recurrence more effectively than current standard-of-care tools, like carcinoembryonic antigen (CEA) tests, which are limited in their ability to identify patients at high risk for recurrence.2

"We are very pleased to be able to make the Guardant Reveal test available to patients with breast and lung cancer, where obtaining a tissue biopsy can be a challenge," said Helmy Eltoukhy, Guardant Health co-CEO. "With a simple blood draw, this test allows oncologists to confidently assess risk for their breast and lung cancer patients so they can quickly identify those patients who may benefit from therapy after surgery, as well as detect cancer recurrence earlier."

The Guardant Reveal test may be initiated as soon as three weeks after surgery. For more information, visit guardantreveal.com.

About Guardant Reveal

Guardant Reveal is the first blood-only test that detects residual and recurrent disease in patients with Stage II and III CRC, breast or lung cancer without the need for a tissue biopsy. Combining genomic and epigenomic signals, the test detects ctDNA in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and to monitor for recurrence of disease in previously diagnosed patients.

On August 15, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, reported financial results for the quarter ended June 30, 2022 (Press release, Gamida Cell, AUG 15, 2022, View Source [SID1234618381]). Net loss for the second quarter of 2022 was $18.6 million, compared to a net loss of $23.6 million in the second quarter of 2021. As of June 30, 2022, Gamida Cell had total cash, cash equivalents and investments of $55.1 million.

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Recently, Gamida Cell:

Received acceptance for filing from the U.S. Food and Drug Administration (FDA) with priority review for its Biologics License Application (BLA) for omidubicel. The BLA has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. If approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant.
Dosed the first patient in a company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201, a readily available cell therapy candidate for the treatment of follicular and diffuse large B-cell lymphomas.
Continued development of the company’s proprietary NAM-enabled NK cell pipeline, including genetically modified product candidates GDA-301, GDA-401, GDA-501 and GDA-601, which aim to treat solid-tumor and hematological cancers. These cell therapy candidates utilize CAR, membrane bound- and CRISPR-mediated technologies to increase the NK cell targeting, potency and persistence against hematologic malignancies and solid tumors. Promising new pre-clinical data on GDA-301 and GDA-601 were presented at the International Society for Cell & Gene Therapy Meeting. The data demonstrated that both NAM-enabled cell therapy candidates represented a novel potent and cytotoxic approach in fighting cancer.
Advanced strategic evaluation for omidubicel commercialization, including assessing whether to commercialize omidubicel ourselves or to pursue strategic alternatives to commercialize omidubicel, upon receipt of regulatory approval. The company currently has sufficient cash to fund the company’s operations into mid-2023, excluding the cost of commercializing omidubicel.
"2022 is a potentially transformative year for Gamida Cell as we continue to execute against our clinical and regulatory milestones. We were excited that the FDA accepted our BLA submission with priority review, and if approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant. We believe that omidubicel has the potential to change the outlook for patients suffering from blood cancers through improved outcomes, quality of life and increased access for patients who are currently eligible for transplant, but cannot find a match," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "In addition, the development of our NAM-enabled NK cell therapy candidate, GDA-201, creates an opportunity to potentially bring a new treatment option to tens of thousands of patients with relapsed/refractory lymphoma worldwide. We continue to execute our mission of advancing our broad pipeline of NAM-enabled cell therapies with a curative approach for patients with solid tumors and blood cancers and other serious blood diseases."

Second Quarter and Recent Developments

Omidubicel: Advanced Cell Therapy

BLA accepted by FDA with Priority Review: In August 2022, the FDA accepted for filing Gamida Cell’s BLA for omidubicel for the treatment of patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant. The FDA granted Priority Review for the BLA and has set a PDUFA target action date of January 30, 2023. In parallel, Gamida Cell is preparing for the commercialization of omidubicel in the U.S.
GDA-201: NAM-Enabled NK Cell Therapy

Dosed the first patient in Phase 1/2 study of cryopreserved formulation of GDA-201: In August 2022, Gamida Cell completed the dosing of the first patient in a company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201 for the treatment of follicular and diffuse B-cell lymphomas.
The Phase 1 portion of the study is designed as a dose escalation phase to evaluate the safety of GDA-201, and will include patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL), marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in 63 patients comprised of two patient cohorts, FL and DLBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant.
NAM-Enabled NK Cell Pipeline Expansion

Progressed NAM-enabled genetically modified NK pipeline: Gamida Cell continues to progress its NAM-enabled genetically modified NK pipeline, which utilizes CAR, membrane bound- and CRISPR-mediated technologies to increase targeting, potency and persistence against hematologic malignancies and solid tumors. The company continues to conduct in vitro and in vivo preclinical proof-of-concept studies for these genetically modified NK therapeutic targets which are already showing encouraging results and plans to select the next NK pipeline product candidate for IND enabling studies by the end of 2022. These therapeutic targets include:
GDA-301: Knockout of CISH (cytokine inducible SH2 containing protein) in NK cells using CRISPR/Cas9 in combination with a membrane-bound IL-15/IL-15Ra;
GDA-401: A development candidate with an undisclosed target;
GDA-501: Anti HER2 CAR-engineered NK cells to target solid tumors expressing HER2, based on a single-chain variable fragment of the widely used humanized monoclonal antibody trastuzumab; and
GDA-601: CRISPR Knockout of CD38 on NK cells combined with anti CD38 CAR. CD38 is an established immunotherapeutic target in multiple myeloma, but its expression on NK cells and its further induction during ex vivo NK cell expansion represents a barrier to the development of an anti CD38 CAR-NK cell therapy. Gamida Cell is advancing this program in collaboration with the Dana-Farber Cancer Institute to study the in vitro cytotoxicity of GDA-601 in fresh tumor tissue samples from multiple myeloma patients.
Corporate Updates

Appointed Ivan M. Borrello, M.D. to Board of Directors: Dr. Borrello is an Associate Professor of Oncology at the Sydney Kimmel Comprehensive Cancer Center at Johns Hopkins and a renowned physician and author who has made major contributions to better the understanding of immunotherapies and the treatment of hematologic malignancies as well as bone marrow transplant. The Company also announced the resignation of Ofer Gonen from its Board of Directors.
Second Quarter 2022 Financial Results

Research and development expenses were $10.6 million in the second quarter of 2022, compared to $13.4 million in the same quarter in 2021. The decrease was attributable mainly to a $2.4 million decrease in clinical activities relating to the conclusion of our Phase 3 clinical trial and a decrease of $0.4 million in the GDA-201 clinical program.
Commercial expenses were $3.2 million in the second quarter of 2022, compared to $5.0 million in the second quarter of 2021. The decrease was attributable mainly to reducing near-term commercial readiness expenses, as we continued to assess strategic approaches for the commercialization of omidubicel.
General and administrative expenses were $4.3 million in the second quarter of 2022, compared to $3.9 million in the same period in 2021. The increase was mainly due to a $0.9 million increase in professional services expenses, offset by a decrease of $0.5 million in headcount related expenses.
Finance expenses, net, were $0.5 million in the second quarter of 2022, compared to $1.3 million in the same period in 2021. The decrease was primarily due to $0.6 million in non-cash expenses and an increase of $0.2 million in interest income from cash management.
Net loss was $18.6 million in the second quarter of 2022, compared to a net loss of $23.6 million in the second quarter of 2021.
2022 Financial Guidance

Gamida Cell expects that its current cash, cash equivalents and investments will support the company’s ongoing operating activities into mid 2023, excluding the cost of commercializing omidubicel. If we decide to market omidubicel ourselves, we will require substantial additional funding. This cash runaway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken. Gamida Cell continues to assess all financing options that support its corporate strategy.

Expected Milestones in 2022 and Early 2023

Omidubicel

PDUFA target action date of January 30, 2023.
NK cell pipeline expansion

Conduct preclinical proof of concept studies of the NAM-enabled, genetically modified NK therapeutic targets
Select pipeline candidate for IND-enabling studies
Conference Call Information

Gamida Cell will host a conference call today, August 15, 2022, at 8:00 a.m. ET to discuss these financial results and company updates. To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit View Source

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the potential treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical study data. Preclinical studies have shown that GDA-201 may address key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, these data suggest GDA-201 may improve antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the currently ongoing GDA-201 Phase 1/2 clinical trial.

For more information about GDA-201, please visit View Source For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

About NAM Technology

Our NAM-enabling technology, supported by positive omidubicel Phase 3 results, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process

On August 15, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that PharmaCyte and Iroquois Master Fund Ltd (Press release, PharmaCyte Biotech, AUG 15, 2022, View Source [SID1234618380]). and its affiliates, the beneficial owners of approximately 6.7% of PharmaCyte’s outstanding shares of common stock, have signed a Cooperation Agreement that includes naming two of Iroquois’ director designees to PharmaCyte’s reconstituted Board of Directors.

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Pursuant to the Agreement, Iroquois’ director designees, Jonathan L. Schechter and Joshua N. Silverman, will join PharmaCyte’s reconstituted Board as independent directors. Jack E. Stover, Daniel S. Farb, and Daniel C. Allen will also join PharmaCyte’s reconstituted Board as independent directors. Existing PharmaCyte directors Kenneth L. Waggoner and Dr. Michael M. Abecassis will complete the 7-member Board.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "We are pleased to have reached this constructive agreement with Iroquois which we believe is in the best interest of all shareholders. Our reconstituted Board combines extensive science, operating and capital markets experience that will make PharmaCyte a much stronger company. I would like to thank all of our previous Board members for their numerous and invaluable contributions, including Dr. Matthias Löhr, Dr. Gerald W. Crabtree, Thomas Liquard, Dr. Raymond C.F. Tong and Carlos Trujillo. Each resigned from the Board as part of the Cooperation Agreement after determining that the Cooperation Agreement, including the composition of the new Board, was in the best interest of the Company moving forward.

"We are nearing the end of our process to fulfill the FDA’s requests to enable the clinical hold to be lifted. To date, approximately 90% of the FDA’s requests have been completed or are in process with one major pig study remaining to be completed. We look forward to integrating our new directors’ ideas to drive our continued development and growth as a Nasdaq biotechnology company focused on developing treatments for hard-to-treat diseases like cancer, diabetes, and malignant ascites."

In addition, Iroquois has agreed to certain customary standstill provisions and will support the Board’s full slate of directors at the 2022 Annual Meeting. The complete agreement between PharmaCyte and Iroquois will be included as an exhibit to PharmaCyte’s Current Report on Form 8-K, which will be filed with the U.S. Securities and Exchange Commission.

Richard Abbe, President of Iroquois, concluded, "We appreciate the engagement we have had with PharmaCyte and its shareholders over the last several months. With the appointment of five new highly qualified directors, the majority of whom are direct shareholder representatives, we are confident that the reconstituted Board is well-poised to unlock value for all shareholders."

Biographies for New Board Members:

Daniel C. Allen is an experienced CEO and public company director with significant investment, financial, and operational experience. Currently, Mr. Allen is the Managing Partner of Corona Park Investment Partners, LLC, a firm he founded, and the Executive Chairman on the Board of Directors of Zagg, a global leader in mobile accessories and technologies. He also served as a Director of SharpSpring, Inc. and as the CEO and Director of Evercel, Inc. Prior to forming Corona Park Investment Partners, LLC, Mr. Allen worked for nearly a decade at Bain Capital where he led more than a dozen investments in venture and late-stage technology companies. He also served as a strategy consultant at McKinsey and Company. He received an undergraduate degree in Economics from Harvard College and an M.B.A. from Harvard Business School.

Daniel S. Farb is an experienced investor and public company director. He is currently the Managing Member of Mill Pond Capital. Previously, Mr. Farb served as a Director of Meg Energy Corp. and as a Managing Director at Highfields Capital Management. Mr. Farb has also worked at Goldman, Sachs & Co. in the Mergers & Acquisitions and Principal Investment Groups. Mr. Farb is a graduate of the Harvard Business School, and holds a Bachelor of Commerce Degree from McGill University.

Jonathan L. Schechter is an experienced public company director with expertise in capital allocation and mergers and acquisitions having worked with public companies for over two decades, including ten years of legal experience and fourteen years of investment banking experience. He is currently a partner of The Special Equities Group, a division of Dawson James Securities, Inc., a full-service investment bank specializing in healthcare, biotechnology, technology, and clean-tech sectors. Mr. Schechter is one of the founding partners of The Special Equities Opportunity Fund, a long-only fund that makes direct investments in micro-cap companies. He currently serves on the board of directors of Synaptogenix, Inc., a clinical-stage biopharmaceutical company. Mr. Schechter earned his A.B. in Public Policy/Political Science from Duke University and his J.D. from Fordham University School of Law.

Joshua N. Silverman is currently the Co-Founder and Managing Member of Parkfield Funding LLC and is a former Principal and Managing Partner of Iroquois Capital Management, LLC. Mr. Silverman served as Co-Chief Investment Officer of Iroquois from 2003 until July 2016. From 2000 to 2003, Mr. Silverman served as Co-Chief Investment Officer of Vertical Ventures, LLC, a merchant bank. Prior to forming Iroquois, Mr. Silverman was a Director of Joele Frank, a boutique consulting firm specializing in mergers and acquisitions. Previously, Mr. Silverman served as Assistant Press Secretary to The President of The United States. Mr. Silverman currently serves on the boards of directors of Ayro Inc., MYMD Pharmaceuticals, Inc., Petros Pharmaceuticals, Inc. and Synaptogenix, Inc. Mr. Silverman received his B.A. from Lehigh University.

Jack E. Stover is an experienced CEO, public company director, and investor with extensive knowledge of corporate governance, capital markets strategies and strategic transactions. He is currently CEO of NorthView Acquisition Corp. and has served as CEO and director of multiple life science companies, including Onconova Therapeutics, Interpace Biosciences, and Antares Pharma, Inc. Mr. Stover was formerly a partner with PricewaterhouseCoopers (then Coopers and Lybrand), working in the bioscience industry division in New Jersey. Mr. Stover received his B.A. in Accounting from Lehigh University.

On August 15, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that its Board of Directors has approved a share repurchase program with authorization to repurchase up to $2.0 million of the Company’s outstanding common stock (Press release, PLUS THERAPEUTICS, AUG 15, 2022, View Source [SID1234618379]). The Company intends to fund any share repurchases with available cash.

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"This share repurchase program reflects our continued confidence in our long-term strategy and the strength of the balance sheet and reinforces our commitment to deliver value to shareholders," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics.

The timing and amount of any shares repurchased will be determined based on the Company’s evaluation of market conditions and other factors, including consent of the Company’s lender. Repurchases may be made from time to time on the open market over the next 12 months, in privately negotiated transactions or by other means, including through the use of trading plans intended to qualify under Rule 10b5-1. Repurchases will be made in accordance with the rules and regulations promulgated by the Securities and Exchange Commission. The Company is not obligated to acquire any shares and the program may be discontinued or suspended at any time.