On July 5, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, and TYME Technologies, Inc. (NASDAQ:TYME), reported that the companies have entered into a definitive merger agreement pursuant to which Syros will acquire TYME, including its pipeline assets and net cash at closing which after accounting for wind-down and transaction expenses is currently estimated to be approximately $60 million (Press release, Syros Pharmaceuticals, JUL 5, 2022, View Source [SID1234616464]). The combined company will trade on Nasdaq under the ticker symbol "SYRS" and will be led by Syros’ existing management team, including Nancy Simonian, M.D., Chief Executive Officer of Syros, and will remain focused on advancing Syros’ pipeline of small molecule medicines for the treatment of cancer.

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Concurrent with the merger, Syros announced an oversubscribed $130 million private investment in public equity (PIPE) financing at a price per unit of $0.94. New and existing investors in the PIPE which was led by a life sciences-focused investment fund include Syros co-founder and founding investor Flagship Pioneering, Avidity Partners, Deep Track Capital, Bain Capital Life Sciences, Invus, Samsara BioCapital, Adage Capital Partners LP, Ally Bridge Group and Cowen Healthcare Investments, as well as other investors. Additionally, Syros stockholders holding approximately 28% of the outstanding shares of Syros common stock and TYME stockholders holding approximately 30% of the outstanding shares of TYME common stock signed support agreements obligating them to vote in favor of the transactions.

Syros also announced an amendment to its senior secured loan facility with Oxford Finance LLC which, subject to certain conditions, will extend the interest-only payment period from March 1, 2023 to March 1, 2024 (and, upon the achievement of certain milestones, September 1, 2024), and will extend the maturity date from February 1, 2025 to February 1, 2026 (and, upon the achievement of certain milestones, August 1, 2026).

Following the closing of the merger, financing and debt agreement amendment, the total cash balance of the combined company is expected to be approximately $240 million (after transaction expenses), sufficient to fund Syros’ planned operating expenses and capital expenditure requirements into 2025.

"This is a pivotal moment for Syros. We believe these transactions will bring us the necessary capital to advance our late-stage clinical programs toward commercialization, including tamibarotene, currently being studied in the SELECT-MDS-1 trial, the randomized portion of the SELECT-AML-1 trial, and SY-2101, which we plan to advance into a Phase 3 trial next year for the treatment of acute promyelocytic leukemia," said Dr. Simonian. "After evaluating safety lead-in data from the SY-5609 Phase 1 trial in pancreatic cancer we will assess the optimal path forward for this

program. Additionally, we have decided to seek partnerships for our oncology discovery programs. Together, these decisions allow us to focus on the most advanced programs across our targeted hematology portfolio where we believe we can more rapidly address significant unmet needs. We are grateful for our new and existing investors, as well as to the TYME team for their spirit of collaboration throughout this process and look forward to delivering on our vision of bringing forward medicines that redefine the standard of care for cancer patients."

"Following an extensive review of numerous strategic alternatives, it was clear that the proposed merger with Syros was the best option for our shareholders," said Richie Cunningham, Chief Executive Officer of TYME Technologies. "The team at Syros shares our unwavering commitment to develop medicines that make a profound difference in patients’ lives. Syros has a robust pipeline with its lead program in Phase 3, an experienced management and board, and now is well capitalized to execute on its clinical endeavors. Additionally, Syros will continue our work of evaluating the best path forward for the SM–88 program."

In conjunction with these strategic transactions, Syros provided an update on the following clinical and discovery programs:

Tamibarotene: Oral RARα Agonist

Higher-Risk Myelodysplastic Syndrome (HR-MDS)

Syros continues to progress the ongoing SELECT-MDS-1 Phase 3 trial in newly diagnosed RARA-positive patients with HR-MDS and remains on track to report topline data in the fourth quarter of 2023 or the first quarter of 2024, with a potential new drug application (NDA) filing expected in 2024.

Acute Myeloid Leukemia (AML)

Syros continues to evaluate tamibarotene in combination with venetoclax and azacitidine in the ongoing SELECT-AML-1 Phase 2 trial in newly diagnosed RARA-positive patients with unfit AML. Syros expects to report clinical activity and safety data from the safety lead-in portion of the study in second half of 2022. Syros also plans to initiate the randomized portion of the trial in an additional eighty RARA-positive unfit AML patients, evaluating the triplet regimen of tamibarotene, venetoclax and azacitidine versus venetoclax and azacitidine with data expected in 2023 or 2024.

SY-2101: Oral Arsenic Trioxide

Syros is advancing the ongoing dose confirmation trial of SY-2101 in patients with newly diagnosed acute promyelocytic leukemia (APL) and expects to announce pharmacokinetic and safety data in mid-2022. Syros now expects to initiate a Phase 3 clinical trial of SY-2101 in the second half of 2023.

SY-5609: Oral Selective CDK7 Inhibitor

Syros is evaluating SY-5609 in combination with chemotherapy in relapsed/refractory metastatic pancreatic cancer patients. The company expects to report safety and clinical activity data from the safety lead-in portion of the trial in the second half of 2022. Based on the safety lead-in data, Syros will determine the best course for further development of SY-5609.

In addition, the arm of Roche’s ongoing Phase 1/1b INTRINSIC trial evaluating SY-5609 in combination with atezolizumab, it’s PD-L1 inhibitor, in BRAF-mutant colorectal cancer is now open for enrollment. Under the terms of Syros’ agreement with Roche, Roche is the sponsor of the trial and Syros is supplying SY-5609.

Gene Control Discovery Engine

Syros is seeking partnerships for its discovery programs, including its CDK12 program. Syros remains on track to nominate a development candidate from its CDK12 program in the third quarter of 2022.

Syros will continue to execute on its existing collaborations with Incyte Corporation and Global Blood Therapeutics, for which its research efforts are fully funded externally, as provided in each agreement.

Transaction Details

In the merger, Syros expects to issue approximately 74.3 million shares of its common stock to TYME stockholders to acquire TYME’s expected net cash at closing and TYME stockholders are expected to receive approximately 0.4312 shares of Syros common stock for each share of TYME common stock. The actual number of shares to be issued in the merger and the exchange ratio will be subject to adjustment based on the amount of TYME’s net cash at closing and the number of TYME shares outstanding at closing. Upon closing of the merger, TYME will become a wholly owned subsidiary of Syros. The merger agreement has been approved by the Board of Directors of each company.

In the PIPE financing, Syros agreed to sell units comprising (i) an aggregate of 138.1 million shares of its common stock and pre-funded warrants to purchase shares of common stock and (ii) accompanying warrants to purchase an aggregate of up to 138.1 million additional shares of common stock (or pre-funded warrants in lieu thereof), at a price per unit of $0.94 (or $0.9399 per unit comprising a pre-funded warrant and accompanying warrant). The exercise price of the warrants is $1.034 per share, or if exercised for a pre-funded warrant in lieu thereof, $1.0399 per pre-funded warrant (representing the warrant exercise price of $1.034 per share minus the $0.0001 per share exercise price of each such pre-funded warrant).

The warrants are exercisable at any time during the period beginning six months after the closing of the PIPE financing and ending five years after such closing. The pre-funded warrants are exercisable at any time after their original issuance and will not expire. The expected gross proceeds from the PIPE financing are $130 million, before deducting estimated offering expenses.

The merger, together with the PIPE financing, is intended to be tax free for U.S. federal income tax purposes to TYME stockholders.

The number of shares of Syros common stock issuable in the PIPE financing and the merger are subject to adjustment in the event of any reverse stock split that may be effectuated by Syros in connection with the transactions.

The transactions are expected to close in the second half of 2022 concurrently with each other, subject to approval by the stockholders of Syros and TYME, the effectiveness of a registration statement to be filed with the U.S. Securities and Exchange Commission (the "SEC") to register the shares of Syros common stock to be issued in connection with the merger and the satisfaction of other customary closing conditions.

Net proceeds from the merger and the PIPE financing are expected to be used to advance Syros’ clinical development pipeline, business development activities, working capital and other general corporate purposes.

The securities to be sold in the PIPE have not been registered under the Securities Act of 1933, as amended ("Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

Management and Organization

Effective as of the closing of the transactions, the Syros leadership team will continue to be responsible for all executive positions of the combined company. Nancy Simonian, M.D., will be the Chief Executive Officer, David A. Roth, M.D., will serve as Chief Medical Officer, Kristin Stephens will serve as Chief Development Officer, Eric Olson, Ph.D., will serve as Chief Scientific Officer, Jason Haas will serve as Chief Financial Officer and Conley Chee will serve as Chief Commercial Officer. Additionally, effective as of the closing of the transactions, Syros expects to add a board member nominated by TYME and a board member nominated by a PIPE investor.

Advisors

Piper Sandler & Co. is acting as financial advisor to Syros. Moelis & Company LLC is acting as financial advisor to TYME. Cowen and Piper are acting as placement agents for the PIPE transaction. WilmerHale LLP is acting as legal counsel to Syros. Faegre Drinker Biddle & Reath LLP is acting as legal counsel to TYME.

Conference Call Information

Syros will host a conference call today, July 5, 2022 at 8:30 a.m. ET, to discuss the transactions. Participants may register for the conference call here. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start.

A live webcast of the call will also be available on the Investors & Media section of the Syros website at View Source

On July 5, 2022 Aurigene’s small molecule drug discovery platform reported The collaboration combines EQRx’s pioneering business model to accelerate the development of drug candidates in the areas of oncology and immune-inflammatory diseases and improve global access to innovative medicines (Press release, Aurigene Discovery, JUL 5, 2022, View Source [SID1234616480]).

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Under the terms of the collaboration agreement, Aurigene and EQRx will collaborate on drug discovery, pre-clinical and clinical development and commercialization. Aurigene will lead drug discovery and pre-clinical development efforts, and EQRx will assume responsibility for clinical development, manufacturing, regulatory and commercialization efforts. The parties would share both funding for the discovery and development of the programs and financials resulting from the commercialization of any eventual drug candidates.

"This agreement with EQRx further validates Aurigene’s proven expertise in discovery and preclinical development of novel therapeutics and moves Aurigene forward into building a global oncology franchise participating in the end-to-end value chain," said Murali Ramachandra, Ph.D., Chief Executive Officer of Aurigene. "We are excited to collaborate with EQRx and contribute to developing and delivering innovative medicines to patients at more affordable prices."

"We are pleased to partner with Aurigene to expand our future pipeline and accelerate the discovery of next-generation therapeutics," said Carlos Garcia-Echeverria, PhD, chief of Rx creation at EQRx. "Our combined efforts will focus on some of the most high-impact therapeutic targets across oncology and immune-inflammatory diseases. Given our mission, we believe these future programs hold the potential to create important treatments for patients and drive meaningful savings for healthcare systems around the world."

On July 5, 2022 Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., and Pierre Fabre Médicament reported they have entered into an exclusive license agreement for Pierre Fabre to register and commercialize vibegron for the treatment of Overactive Bladder (OAB) in the European Economic Area, UK, and Switzerland, with some option territories, which notably include French-speaking countries of Sub-Saharan Africa, Turkey, and certain Eastern European countries (Press release, Pierre Fabre, JUL 5, 2022, View Source [SID1234616481]). Urovant will retain full rights in the United States and other select markets.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are thrilled to partner with Pierre Fabre, a leader in the international biopharmaceutical space," said Jim Robinson, Chief Executive Officer of Urovant Sciences. "Their experience in the global OAB and Benign Prostatic Hyperplasia (BPH) market make them uniquely suited to deliver vibegron to more patients who need it across Europe and surrounding areas."

Under the terms of the agreement, Urovant Sciences will receive payments up to USD $75 million, based on upfront, regulatory, and sales milestone payments. Additionally, Urovant will receive royalties based on sales performance.

Urovant Sciences and Pierre Fabre will share responsibility for vibegron clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.

"We are delighted to enter into this partnership with Urovant, which will bring effective treatment and improved quality of life to all patients suffering from Overactive Bladder (OAB) in Europe. This partnership confirms Pierre Fabre’s extensive expertise in urology and in women’s health for five decades and the group’s ambitions to offer therapeutic solutions to chronic diseases that are very disabling in everyday life," said Eric Ducournau, group CEO at Pierre Fabre.

About Overactive Bladder

Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1

While 33 million US adults experience the bothersome symptoms of OAB, approximately 546 million people ≥ 20 years are affected by OAB worldwide. 1,2

On July 5, 2022 Alpha Tau Medical Ltd. (Nasdaq: DRTS) ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that it will host a hybrid in-person/virtual key opinion leader (KOL) meeting at Convene (North Hub Room), located at 530 5th Ave. New York, NY on Monday, July 18, 2022 beginning at 10:30 am Eastern Time (Press release, Alpha Tau Medical, JUL 5, 2022, View Source [SID1234616466]). For those attending in-person, breakfast will begin at 10:30 am Eastern Time. For those attending virtually, the presentations and webcast will begin at 11:00 am Eastern Time.

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The meeting will feature presentations from KOLs Michael J. Zelefsky, MD, Memorial Sloan Kettering Cancer Center, Mark D’Andrea, MD, University Cancer Centers, and Robert Den, MD, Alpha Tau’s Chief Medical Officer, who will discuss Alpha Tau’s therapy (the Alpha DaRT radiation technology) and the Company’s clinical trial outlook. For those attending the event in person, a selection of the Company’s proprietary applicators will also be available for demonstration.

The Alpha DaRT technology is based on inserting directly into the tumor small amounts of radioactive radium-224 affixed to metal sources which are designed to decay and release radioactive atoms that diffuse inside the tumor, emitting short-range alpha radiation that aims to damage and kill cancer cells within a short period of time.

During the KOL presentations, Alpha Tau’s recent clinical trials, upcoming U.S. pivotal trial in recurrent cutaneous Squamous Cell Carcinoma (SCC), other upcoming clinical trials, and the Company’s pre-clinical work on potential immunological effects of the Alpha DaRT technology will be discussed.

A Q&A session will follow the formal presentations. To register for the event or webcast, please click here. If you would like to attend in person, please indicate this selection when registering and you will receive an email confirming your attendance closer to the event with specific location details.

Michael J. Zelefsky, MD is an internationally renowned radiation oncologist who is Professor of Radiation Oncology at Memorial Sloan Kettering Cancer Center and the Weil Cornell Medical Center. He serves as the Chief of the Brachytherapy Service at MSKCC which represents one of the most active sites for performing brachytherapy in the world, involved in highly innovative and sophisticated oncology procedures incorporating the delivery of radiation-based implants directly into tumors. Dr Zelefsky is the incumbent Greenberg Chair of Prostate Cancer Research at MSKCC and serves as the Co-Leader of the Genitourinary Disease Management team for the hospital as well as the Director of GU Radiation Oncology. He has published over 400 papers in Oncology as well as Book Chapters and Reviews. He also serves as the Editor in Chief of the Journal Brachytherapy.

Mark D’Andrea, MD is a board-certified Radiation Oncologist providing services in Houston, Brenham, and Huntsville. Primarily affiliated with University Cancer Centers, Dr. D’Andrea has been named one of Houston’s Top Doctors from 2016 through 2021. He has received the Patient’s Choice award, Most Compassionate Doctor, and Peer Reviewed Physician, among several other distinctions over the years. Dr. D’Andrea has over 30 years of expertise in breast cancer, prostate cancer, lung cancer, head and neck cancer, gastrointestinal cancer, and gynecologic cancer treatments. Dr. D’Andrea has been published in over 30 clinical medical research publications.

Robert Den, MD has served as Alpha Tau’s Chief Medical Officer since 2019. Dr. Den specializes in radiation oncology and conducts innovative research across a broad variety of malignancies. From 2011 to 2015 and from 2015 to the present, Dr. Den has served as an assistant professor and an associate professor, respectively, at Jefferson University, where he has also served as a clinical practitioner since 2007. Dr. Den holds a B.S. in Chemistry from Yale University and an M.D. from Harvard Medical School.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On July 5, 2022 Boehringer Ingelheim, a leading research-driven biopharmaceutical company, the life science company Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and bioMérieux, a world leader in in vitro diagnostics, reported that they have formed a joint venture to create the next generation of antimicrobials along with actionable diagnostics to fight Antimicrobial Resistance (AMR) (Press release, Boehringer Ingelheim, JUL 5, 2022, View Source [SID1234616482]).

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The resulting company, Aurobac Therapeutics SAS, will combine the best capabilities of the three founding companies towards developing a new precision medicine approach, from diagnosis to cure. The aspiration is to succeed in the fight against AMR, which is a major public health threat. Having routine surgery such as caesarean sections or hip replacements may become life threatening, and complications from common diseases such as diabetes and injuries or cuts will become harder to manage because of growing resistance to antibiotics in patients.

"The rise of antibiotic-resistant infections – also called antimicrobial resistance, or AMR – is indeed a looming global crisis," said Michel Pairet, Head of Boehringer Ingelheim’s Innovation Unit and Member of the Board of Managing Directors. "Antibiotic resistance kills about 1.27 million people globally every year1 and it has been estimated that by 2050, as many as 10 million worldwide deaths could result from AMR2, making it potentially deadlier than cancer."

Werner Lanthaler, CEO of Evotec added: "The grim prospect of a post-antibiotic era has many causes but only one solution: The development of new, targeted, and effective antimicrobial therapies. We are excited to launch Aurobac together with our partners at Boehringer Ingelheim and bioMérieux, to combine our complementary strengths. By leveraging Evotec’s multimodality approach to infectious diseases, we are confident that Aurobac will be able to generate much-needed progress to tackle the global challenge of AMR."

"bioMérieux has a strong expertise in antimicrobial resistance. We supply the most comprehensive integrated diagnostic solutions to support an appropriate use of antibiotics (antimicrobial stewardship)," said Alexandre Mérieux, bioMérieux Chairman and CEO. "Our role within the joint venture is to develop and commercialize diagnostic tests, including Companion Diagnostics, which deliver rapid, reliable and actionable results. This participation in Aurobac is perfectly aligned with bioMérieux’ full commitment to sustain antibiotic efficacy for future generations."

Aurobac will work to shift the strategy related to antibiotic treatment regimens which at the moment leans heavily on empirical approaches using broad-spectrum and unfocused medicines. The goal is to turn this into a precision approach, using new highly effective and targeted modalities, combined with rapid and actionable diagnostics to quickly identify pathogens and their resistance patterns, and supported by new economic models.

Funded by Boehringer Ingelheim as lead investor with 30 million EUR and by Evotec and bioMérieux with 5 million EUR each, the 40 million EUR joint venture, which has its headquarters in Lyon (France), combines the world leading expertise of Evotec, one of the most active research companies in infectious diseases, with bioMérieux’s market-leading expertise in infectious disease diagnostics and with Boehringer Ingelheim’s broad drug discovery and significant clinical development capabilities.

Three partners committed to combat AMR

Boehringer Ingelheim’s participation in Aurobac is part of a wider so-called pandemic preparedness initiative, which includes a 50 million EUR investment in the AMR action fund by Boehringer Ingelheim. Boehringer Ingelheim Venture Fund has committed to invest up to 12 million EUR in AMR infection companies.

bioMérieux has over 55 years of diagnostics expertise with more than 75 percent of its research and development budget focused on antimicrobial resistance. Moreover, 80 percent of its turnover is related to the fight against AMR through a complete diagnostic solution facilitating antibiotic therapy decision-making, including antibiotic initiation, optimization, and discontinuation.

Evotec has built a world-leading platform to tackle infectious diseases. With a more than 200-strong anti-infective discovery team, the company has proven experience on multiple agent classes. On top of the company’s own pre-competitive pandemic preparedness and rapid response technology platform ("PRROTECT"), Evotec leverages its infectious disease capabilities with many industry, academic and non-profit partners and is active in a variety of networks such as the AMR Accelerator that is part of the EU’s Innovative Medicines Initiative ("IMI").