On August 9, 2022 Catalent, Inc. (NYSE: CTLT), the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, reported that it has reached an agreement to acquire Metrics Contract Services (Metrics), a full-service specialty Contract Development and Manufacturing Organization (CDMO) with a facility in Greenville, North Carolina, for $475 million from Mayne Pharma Group Limited (ASX: MYX) (Mayne Pharma) (Press release, Catalent, AUG 9, 2022, View Source [SID1234617965]). Upon completion, the acquisition will strengthen Catalent’s capabilities in integrated oral solid formulation development, manufacturing, and packaging to help customers simplify and accelerate their programs, while also expanding Catalent’s capacity to handle highly potent compounds.

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The 333,000 square-foot Greenville facility features comprehensive capabilities to accelerate and de-risk customer programs from early development through commercial launch through a streamlined one-site solution. Over the past five years, the facility has seen more than $100 million in capital improvements and now includes 16 manufacturing suites, with 11 designed to handle highly potent compounds, as well as two packaging lines that can support a large variety of development and commercial supply programs. The facility’s estimated annual production capacity exceeds one billion oral solid dose units.

"This acquisition will further expand Catalent’s ability to meet our customers’ expectations in fast-growing areas of the business and patient need. The experienced team and consistently improved, state-of-the-art facility in Greenville will provide Catalent’s customers with immediate, fit-for-scale capacity for in-demand highly potent drugs and other oral solid small-to-mid-size batch needs. This capacity is particularly important for customers with R&D pipelines featuring accelerated, orphan, and rare disease programs for oncology and other important therapeutic areas," said Dr. Aris Gennadios, Group President of Catalent’s Pharma & Consumer Health segment.

"Over the past several years, Metrics has undergone a period of transformational change to expand its footprint and service offering, becoming a global end-to-end novel oral solid CDMO. Catalent, a global leader in advanced drug development and manufacturing, is well-positioned to continue to invest in and accelerate the growth of Metrics and we believe this transaction will be extremely positive for our Greenville team and customers," said Scott Richards, Chief Executive Officer of Mayne Pharma.

The new facility will seamlessly integrate into Catalent’s industry-leading oral development and manufacturing network, which includes flagship sites for large-scale and controlled release oral solids manufacturing in Winchester, Kentucky; softgel development and manufacturing in St. Petersburg, Florida; and additional facilities with bioavailability enhancement technologies and complex oral solids manufacturing platforms.

The acquisition is expected to close before the end of this calendar year, subject to customary closing conditions, and the entire team of over 400 employees will join Catalent. Mayne Pharma and Catalent have also agreed on the terms of a long-term supply agreement whereby the Greenville facility will continue to manufacture multiple Mayne Pharma products. Catalent will pay the purchase price for this all-cash acquisition using a combination of cash on hand, existing credit facilities, and, depending on market conditions, potentially new debt financing. The closing of the acquisition is not contingent on any financing activity.

On August 9, 2022 HCA Healthcare, Inc. (NYSE: HCA), one of the nation’s leading healthcare providers, reported that it will collaborate with Johnson & Johnson to address key healthcare industry issues (Press release, Johnson & Johnson, AUG 9, 2022, View Source [SID1234617964]).

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The two leading healthcare companies initially will focus on improving health equity, enhancing nursing support, and improving patient outcomes:

HCA Healthcare and Johnson & Johnson will collaborate on a scalable program to improve health outcomes through early-stage lung cancer detection for the Black community. Lung cancer is the number one cause of cancer death among Black patients1, and the two companies will begin to work together on a pilot program in the coming months to increase early identification.
HCA Healthcare, which has more than 93,000 nurses in its system, and Johnson & Johnson have a long-standing commitment to advocating for and supporting nurses. The two healthcare leaders will work together to incorporate Johnson & Johnson’s nursing resources within HCA Healthcare and its affiliate Galen College of Nursing. The companies will work together on health equity issues focused on educational programming, training and other programs that elevate and support nurses with a goal of enriching the nursing experience and skillsets and improving patient outcomes.
HCA Healthcare, through its HCA Healthcare Research Institute, and Johnson & Johnson will collaborate on cardiovascular health initiatives including a retrospective analysis of patients who suffer from heart arrhythmia, as well as research to understand the role digital health technology plays in impacting clinical outcomes for patients with Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD) diseases.
"HCA Healthcare and Johnson & Johnson have had a long and productive relationship, and both companies have worked very hard to address many of our country’s healthcare challenges," said Sam Hazen, chief executive officer of HCA Healthcare. "We believe strongly in the power of strategic partnerships, and we are excited to collaborate to advance health equity, enhance patient care and provide even greater support to our nurses."

"No one company can solve society’s most pressing health challenges alone — it takes collaboration," said Joaquin Duato, chief executive officer of Johnson & Johnson. "That’s why we’re working with HCA Healthcare to improve patient access and outcomes, address the nursing crisis, and advance health equity. We are united in our focus to improve patient care."

HCA Healthcare uses data from more than 35 million annual patient encounters to continually improve care. In addition, with more than 93,000 Registered Nurses (RN), HCA Healthcare is one of the country’s top employers of RNs and invests significantly in nurses and nursing through education and professional development, equipment and technology, resources to promote their physical and emotional wellbeing, and representation at every level of the organization from the bedside to senior leadership.

On August 9, 2022 BioMarker Strategies reported that the journal CANCER BIOTHERAPY AND RADIOPHARMACEUTICALS has published a manuscript by the Company’s scientists entitled "Functional Profiling of Head and Neck/Esophageal Squamous Cell Carcinoma to Predict Cetuximab Response" (Press release, BioMarker Strategies, AUG 9, 2022, View Source [SID1234617963]). The manuscript describes the company’s progress in identifying predictive dynamic biomarkers to help identify the subset of patients with head and neck/esophageal squamous cell carcinoma (SCC) who may benefit from treatment with cetuximab (Erbitux) and biosimilars.

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Cetuximab is an antibody that targets an epidermal growth factor receptor (EGFR), and remains the only targeted therapy approved by the U.S. Food and Drug Administration (FDA) for SCC of head and neck/esophagus. For primary SCC, cetuximab is approved for use in combination with radiation. In metastatic SCC, it is approved for use in combination with platinum chemotherapy and fluorouracil.

The authors note that responses to cetuximab can be dramatic, but the response rate was only about 15% in the landmark clinical trial. The authors also note that cetuximab therapy is accompanied by a risk of serious adverse events that results in interrupted therapy in 3%-10% of patients. The cost of treatment is approximately $100,000 per patient. Additionally, immune checkpoint inhibitors are now an option in SCC. Therefore, methods to identify patients who are most likely to respond to cetuximab are needed.

SCC is the world’s sixth most common cancer. Worldwide, there are approximately 900,000 new cases and 450,000 deaths per year. In the United States alone there are approximately 66,630 new cases and 14,620 deaths per year.

"To minimize risk and maximize the therapeutic benefit of cetuximab, predictive tests to better identify patients likely to be responsive to cetuximab therapy are clearly an important need," said Jerry Parrott, President and CEO of BioMarker Strategies. "From my perspective, based on the results reported here, I would agree with the authors that further studies are warranted to test in more complex samples, including patient-derived tumor tissues."

The research described in the manuscript discussed here was supported by a Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).

On August 9, 2022 AbCellera (Nasdaq: ABCL), a technology company with a centralized operating system for next-generation antibody discovery, reported financial results for the second quarter of 2022 (Press release, AbCellera, AUG 9, 2022, View Source [SID1234617962]). All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"We have further strengthened our balance sheet as we execute on our strategy, extending our competitive advantage in antibody discovery and creating value through partnerships," said Carl Hansen, Ph.D., CEO and President of AbCellera. "We continue to invest in technology development, including advancements in our CD3 bispecific platform for creating optimal T-cell-engager therapies for cancer, which we believe will create significant value for patients, our partners, and our shareholders."

Q2 2022 Business Summary

Earned $46 million in total revenue.
Incurred net loss of $7 million, compared to a net loss of $2 million in Q2 2021.
Added six programs under contract with two new partners, resulting in a cumulative total of 164 programs under contract with 38 different partners.
Started discovery on four programs, bringing the cumulative number of program starts to 88.
Continuing to report six molecules cumulatively advanced to the clinic.
Key Business Metrics

AbCellera added six discovery programs in Q2 to reach a cumulative total of 164 discovery programs as of June 30, 2022 (up from 138 on June 30, 2021), that are either completed, in progress, or under contract with 38 different partners (up from 33 on June 30, 2021). AbCellera started discovery on an additional four programs in Q2 to reach a cumulative total of 88 program starts (up from 60 on June 30, 2021). AbCellera’s partners have advanced a cumulative total of six molecules into the clinic.

Discussion of Q2 2022 Financial Results

Revenue – Total revenue was $45.9 million, compared to $27.6 million in Q2 2021. Royalties associated with bebtelovimab were $33.2 million. The partnership business produced research fees of $12.5 million, compared to $5.2 million in Q2 2021. Licensing revenue was $0.1 million.
Research & Development (R&D) Expenses – R&D expenses were $26.7 million, compared to $15.0 million in Q2 2021, reflecting continuing investments in the capacity and capabilities of AbCellera’s discovery and development platform.
Sales & Marketing (S&M) Expenses – S&M expenses were $3.1 million, compared to $1.3 million in Q2 2021.
General & Administrative (G&A) Expenses – G&A expenses were $14.4 million, compared to $11.2 million in Q2 2021, with the increase driven by investments to support the growth of the company.
Net Loss – Net loss was $6.8 million, or ($0.02) per share on both a basic and diluted basis compared to a net loss of $2.3 million, or ($0.01) per share on a basic and diluted basis in Q2 2021.
Liquidity – $1,022 million of cash, cash equivalents, and marketable securities.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

On August 2, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended June 30, 2022 and provided a corporate update (Press release, Syros Pharmaceuticals, AUG 9, 2022, View Source [SID1234617961]).

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"We are entering the second half of the year in a position of strength with multiple data readouts expected over the next 18 months and, following the anticipated closing of our previously announced merger with TYME Technologies and concurrent PIPE financing, we expect to have a robust balance sheet," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "The gross proceeds of approximately $190 million from these transactions, together with the amendment to our existing loan facility, are expected to extend our cash runway into 2025, at least one year beyond expected pivotal data from our ongoing SELECT-MDS-1 trial."

Dr. Simonian continued, "Today, we reported promising preliminary data from our ongoing dose confirmation trial of SY-2101, our novel oral form of arsenic trioxide. Based on the pharmacokinetic data available to date, SY-2101 achieved exposures comparable to IV arsenic trioxide and demonstrated high oral bioavailability. The totality of data with our oral arsenic trioxide continues to support a favorable safety and tolerability profile, giving us further confidence that SY-2101 has the potential to replace the standard-of-care for acute promyelocytic leukemia patients. Based on recent feedback received from the EMA, Syros plans to conduct a singular registration trial for SY-2101 that could support approval in both the United States and the European Union."

UPCOMING MILESTONES

Tamibarotene: Oral RARα agonist

Higher-Risk Myelodysplastic Syndrome (HR-MDS)

On track to report pivotal data from the SELECT-MDS-1 trial in newly diagnosed RARA-positive patients with HR-MDS in the fourth quarter of 2023 or the first quarter of 2024, with a potential new drug application (NDA) filing expected in 2024.
Acute Myelodysplastic Syndrome (AML)

On track to report safety and clinical activity data from the safety lead-in portion of the ongoing SELECT-AML-1 Phase 2 trial in RARA-positive patients with newly diagnosed unfit AML in the second half of 2022.
Expect to initiate the randomized portion of the SELECT-AML-1 Phase 2 trial in an additional eighty patients evaluating the triplet regimen of tamibarotene, venetoclax and azacitidine compared to venetoclax and azacitidine with data expected in 2023 or 2024.
SY-2101: Oral arsenic trioxide (ATO)

Expect to initiate the Phase 3 trial of SY-2101 for the treatment of acute promyelocytic leukemia (APL) in the second half of 2023.
SY-5609: Oral selective CDK7 inhibitor

On track to report safety and clinical activity data from the safety lead-in portion of the ongoing Phase 1 trial evaluating SY-5609 in combination with chemotherapy in relapsed/refractory metastatic pancreatic cancer in the second half of 2022.
RECENT PIPELINE HIGHLIGHTS

Today, Syros announced promising preliminary data from newly diagnosed APL patients enrolled to date in the dose confirmation trial of SY-2101. This is the first cross-over data directly comparing the pharmacokinetics (PK) of SY-2101 to the approved IV dose ATO. SY-2101 administered at 15 mg achieved comparable PK (AUC and Cmax) exposures to IV ATO administered at 0.15 mg/kg. Additionally, SY-2101 showed high oral bioavailability of approximately 80% and continues to support a favorable tolerability profile.
In July, Syros received European Medicines Agency (EMA)/ Committee for Medicinal Products for Human Use (CHMP) scientific advice on the SY-2101 Phase 3 trial design in front line APL. The feedback informs Syros’ plan for a singular registration trial for SY-2101 that could support approval in both the United States (US) and the European Union (EU).
In July, the EMA issued a positive opinion on the Company’s application for orphan drug designation for tamibarotene for the treatment of MDS. The EMA’s orphan designation is available to companies developing treatments for life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 persons in the EU. Medicines that meet the EMA’s orphan designation criteria qualify for financial and regulatory incentives, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase and access to centralized marketing authorization.
In June, Syros announced that based on results from over 175 MDS patients, the company now estimates that approximately 50% of patients with MDS are RARA-positive, as compared to the previously estimated 30%.
Roche is now actively enrolling patients in the arm of its ongoing Phase 1/1b INTRINISIC trial evaluating SY-5609 in combination with atezolizumab, its PD-L1 inhibitor, in BRAF-mutant colorectal cancer patients. Under the terms of Syros’ agreement with Roche, Roche is the sponsor of the trial and Syros is supplying SY-5609.
In July, Syros advanced its oral, potent, and selective CDK12 inhibitor, SY-12882, to development candidate. Preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrated that selective CDK12 inhibition resulted in strong anti-tumor activity as a single agent as well as in combination with a DNA damaging agent and in combination with a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor in models of breast, lung, and ovarian cancer.
CORPORATE

In July, Syros announced that it plans to raise approximately $190 million through a merger with TYME Technologies and an oversubscribed private investment in public equity (PIPE) financing. The $130M PIPE was led by a life sciences-focused investment fund, with participation from new and existing investors, including Syros co-founder and founding investor Flagship Pioneering, as well as Avidity Partners, Deep Track Capital, Bain Capital Life Sciences, Invus, Samsara BioCapital, Adage Capital Partners LP, Ally Bridge Group and Cowen Healthcare Investments. The transactions are expected to close concurrently with each other in the second half of 2022, subject to approval by the stockholders of Syros and TYME and the satisfaction of other customary closing conditions.
Concurrently, Syros amended its senior secured loan facility with Oxford Finance LLC (Oxford) to, subject to certain conditions, extend the interest-only payment period to March 1, 2024 (and, upon the achievement of certain milestones, September 1, 2024), and extend the maturity date to February 1, 2026 (and, upon the achievement of certain milestones, August 1, 2026).
Also in July, Syros announced that it is seeking partnerships for all its wholly owned discovery programs. The Company will continue to execute on its existing collaborations with Incyte Corporation (Incyte) and Global Blood Therapeutics (GBT), for which its research efforts are fully funded, as provided in each agreement.
Second Quarter 2022 Financial Results

Revenues were $6.3 million for the second quarter of 2022, consisting of $5.7 million in revenue recognized under Syros’ collaboration with GBT and $0.6 million recognized under its collaboration with Incyte. Syros recognized $5.2 million in revenue in the second quarter of 2021, consisting of $3.3 million in revenue recognized under its collaboration with GBT and $1.9 million recognized under its collaboration with Incyte.
Research and development expenses were $33.1 million for the second quarter of 2022, as compared to $25.8 million for the second quarter of 2021. This increase was primarily due to the increase in costs associated with the continued advancement of our clinical and preclinical programs and employee-related expenses.
General and administrative (G&A) expenses were $6.9 million for the second quarter of 2022, as compared to $5.5 million for the second quarter of 2021. This increase was primarily due to an increase in employee-related expenses.
For the second quarter of 2022, Syros reported a net loss of $34.5 million, or $0.54 per share, compared to a net loss of $22.5 million, or $0.36 per share, for the same period in 2021.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of June 30, 2022 were $86.3 million, as compared with $143.4 million on December 31, 2021. Based on Syros’s current operating plan and without giving effect to the merger with TYME, the PIPE financing and the loan amendment with Oxford, the completion of which cannot be assured, Syros anticipates that its cash, cash equivalents and marketable securities of $86.3 million as of June 30, 2022 will allow it to meet its liquidity requirements into the second quarter of 2023.

If Syros completes the merger with TYME and the PIPE financing and gives effect to certain provisions of the loan amendment with Oxford related to such closings (which is expected to occur in the second half of 2022), Syros anticipates having approximately $240 million in cash and other capital resources (after transaction expenses), which it believes will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2025.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2022 financial results and provide a corporate update.

To access the live conference call, please dial (833) 636-1323 (domestic) or (412) 902-4279 (international) and refer to the "Syros Pharmaceuticals Conference Call." A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.