On August 9, 2021 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the second quarter ended June 30, 2021 and provided pipeline updates (Press release, AnaptysBio, AUG 9, 2021, View Source [SID1234586124]).

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"We continue to make progress in advancing our wholly-owned pipeline and look forward to multiple clinical data readouts over the upcoming 18 months," said Hamza Suria, president and chief executive officer of AnaptysBio. "The recent approval of JEMPERLI, which is the first AnaptysBio-generated antibody to be approved in the US and EU, validates AnaptysBio’s antibody discovery platform and provides additional revenues to support our capital-efficient business model."

Imsidolimab (Anti-IL-36 Receptor) Program

Following an end-of-Phase 2 meeting with the FDA in Q2, we publicly disclosed trial designs for our imsidolimab generalized pustular psoriasis (GPP) Phase 3 trials, called GEMINI-1 and GEMINI-2. We anticipate initiating GEMINI-1 in Q3 2021. The primary endpoint of our Phase 3 program is the proportion of patients achieving clear or almost clear skin as determined by a Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) score of zero or 1 at week 4 of GEMINI-1, while GEMINI-2 is designed for 6 months of safety follow-up assessment.
We continue to enroll GPP patients in our worldwide registry of GPP patients, called RADIANCE, which is designed to improve our understanding of GPP patient journeys and support enrollment of our GEMINI Phase 3 trials. Medical claims analyses recently conducted by IQVIA indicate approximately 37,000 unique patients were diagnosed with GPP at least once, and approximately 15,000 unique patients were diagnosed with GPP at least twice, in the United States by a physician between 2017 and 2019 using the International Classification of Diseases 10th Revision (ICD-10) billing code pertaining to GPP (L40.1).
Full data from our completed Phase 2 GALLOP trial of imsidolimab in GPP, including efficacy and safety of imsidolimab treatment through week 16, will be disclosed in an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress on October 2nd, 2021.
We are continuing to advance imsidolimab through Phase 2 clinical trials in multiple additional indications associated with IL-36 signaling dysfunction. Our 120-patient placebo-controlled ACORN Phase 2 trial of imsidolimab in moderate-to-severe acne is anticipated to read out top-line data in the first half of 2022. Imsidolimab is also being tested versus placebo in hidradenitis suppurativa, where our 120-patient HARP trial is anticipated to generate top-line data in the second half of 2022. We continue to enroll our 45-patient placebo-controlled EMERGE Phase 2 trial of imsidolimab in EGFR/MEK-mediated skin toxicities, where we anticipate an interim analysis by the end of 2021. We also continue to enroll patients in our INSPIRE Phase 2 trial in ichthyosis where top-line data is anticipated during 2022.
Rosnilimab (Anti-PD-1 Agonist) Program

We anticipate top-line data in Q4 2021 from our ongoing Phase 1 healthy volunteer clinical trial of rosnilimab, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of rosnilimab in single and multiple ascending dose cohorts.
We plan to initiate a placebo-controlled Phase 2 clinical trial of rosnilimab in alopecia areata in Q4 2021.
ANB032 (Anti-BTLA Modulator) Program

We are advancing ANB032, our wholly-owned BTLA modulator antibody, in a healthy volunteer Phase 1 single and multiple ascending dose clinical trial where top-line data is anticipated during the first half of 2022.
GSK Partnered Programs

JEMPERLI (dostarlimab), our proprietary anti-PD-1 antagonist antibody, was approved by the FDA and the European Medicines Agency (EMA) during April 2021 for treatment of advanced or recurrent mismatch repair deficient endometrial cancer. This is the first AnaptysBio-generated antibody, of eight currently under clinical development, to obtain regulatory approval. GSK has recently disclosed peak annual sales estimates of £1-£2 billion for JEMPERLI, and AnaptysBio will earn 8-25% royalties on global net sales of JEMPERLI. We received $20 million and $10 million milestone payments upon FDA and EMA approval of JEMPERLI, respectively. We anticipate earning an additional $20 million milestone payment upon a second FDA BLA approval for JEMPERLI in pan-deficient mismatch repair tumors during the second half of 2021. AnaptysBio is due an additional $15 million and $165 million upon certain JEMPERLI regulatory and commercial milestones, respectively.
Second Quarter Financial Results

Cash, cash equivalents and investments totaled $396.3 million as of June 30, 2021, compared to $411.2 million as of December 31, 2020, for a decrease of $14.9 million. The decrease relates primarily to cash used for operating activities.
Collaboration revenue was $30 million and $41.3 million for the three and six months ended June 30, 2021. The $30 million earned during the second quarter relates to milestone revenue for the US and EU approval of JEMPERLI (dostarlimab), compared to zero and $15 million of milestone revenue for the three and six months ended June 30, 2020.
Research and development expenses were $25.3 million and $49.5 million for the three and six months ended June 30, 2021, compared to $17.9 million and $38.9 million for the three and six months ended June 30, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
General and administrative expenses were $5.2 million and $10.7 million for the three and six months ended June 30, 2021, compared to $4.7 million and $9 million for the three and six months ended June 30, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
Net loss was $0.4 million and $18.6 million for the three and six months ended June 30, 2021, or a net loss per share of $0.02, and $0.68, compared to a net loss of $21.5 million and $29.8 million for the three and six months ended June 30, 2020, or a net loss per share of $0.79 and $1.09.
Financial Guidance

AnaptysBio expects its net cash burn in 2021 will be less than $100 million. We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2024.

On August 9, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported financial results for the second quarter of 2021 (Press release, Agenus, AUG 9, 2021, View Source [SID1234586140]).

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"In the first half of this year, we announced a collaboration with BMS and advanced our flagship clinical candidate AGEN1181 to an important data inflection point," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "In the second half, we will disclose this data at a key cancer conference and be ready with our commercial platform in preparation for a balstilimab launch."

AGEN1181 (Fc-enhanced anti-CTLA-4): Clinical data support superior activity in difficult-to-treat cancers

Updated clinical data for AGEN1181 alone and in combination with balstilimab will be presented at an upcoming conference.

Clinical responses seen in patients refractory to approved immunotherapies, including patients with microsatellite stable (MSS) tumors and melanoma, endometrial, and ovarian cancer with the low-affinity FcyRIIIA allele. No immune mediated hypophysitis, pneumonitis, or hepatitis (typically seen with first generation anti-CTLA-4s) were reported.

Registrational trials targeted to commence by year-end 2021 with a focus on rapid path to Biologics License Application (BLA) submission.
MiNK Therapeutics: Allogeneic iNKT cell therapy company advances towards IPO

MiNK Therapeutics (currently an Agenus company) filed a confidential S-1 to support a planned Initial Public Offering (IPO).

Phase 1 trial of AGENT-797 in hematologic cancers dose cohorts completed with data readouts planned in the second half of 2021; Phase 1/2 expansion trials in viral acute respiratory distress syndrome (ARDS) are underway.
AGEN1777 (Fc-enhanced anti-TIGIT bispecific): Collaboration with BMS provides additional cash resources to advance Agenus’ high value drivers

Global exclusive license with Bristol Myers Squibb for AGEN1777 provides $200 million upfront cash. In addition, Agenus to receive up to $1.36 billion in development, regulatory, and commercial milestones, and tiered double-digit royalties upon product sales.

FDA cleared Investigational New Drug (IND) application; Phase 1 dosing with AGEN1777 alone and in combination with an anti-PD-1 in advanced solid tumors planned to begin this quarter.
Balstilimab (anti-PD-1): BLA accepted for Priority Review by U.S. FDA; data updates presented at ASCO (Free ASCO Whitepaper)

Balstilimab BLA accepted for Priority Review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2021.

Commercial preparation underway for a highly efficient, targeted launch to provide broad product access to physicians and patients while laying the foundation for future Agenus products.

Clinical data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting:

Phase 2 data for balstilimab showed a response rate of 20% in PD-L1 positive tumors, overall response rate of 15%, and median duration of response of 15.4 months.
Balstilimab showed superior tumor killing compared to approved anti-PD-1s such as pembrolizumab and nivolumab.

Results from a Phase 2 trial of balstilimab plus zalifrelimab combination in recurrent or metastatic cervical cancer to be presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 on September 19 from 11:35 – 11:40am ET.
Additional programs

Phase 1 data for AGEN2373, a CD137 agonist antibody, in patients with advanced solid tumors were presented at ASCO (Free ASCO Whitepaper) 2021.

No dose limiting toxicities were seen at doses up to 3 mg/kg, including no liver toxicity. Combination trials are in planning.

Process for scale up of QS-21 manufacturing continues to advance.

VISION platform knowledge base expanding to support AGEN1181 response prediction and combination discovery.
Management appointments

Steven O’Day, MD appointed to Chief Medical Officer.

Andy Hurley appointed to Chief Commercial Officer.

Marc Wiles, PhD appointed to Vice President of Regulatory Affairs.

Julie DeSander promoted to Chief Business Officer.

Joseph Grossman, MD, appointed to Vice President of Exploratory Medicine.

Jason Paragas appointed to Vice President of Data Sciences.

Jennifer Buell, PhD, appointed to Chief Executive Officer of MiNK Therapeutics. Dr. Buell will continue as a member of the Agenus Executive Committee.
Second Quarter Financial Results

We ended the second quarter of 2021 with a cash balance of $74 million as compared to $100 million at December 31, 2020. Subsequent to the quarter end we received $200 million related to our BMS partnership.

For the second quarter ended June 30, 2021, our cash used in operations was $56 million and we reported a net loss of $84 million or $0.37 per share which included a number of non-cash items. This compares to cash used in operations for the same period in 2020 of $37 million and a net loss of $48 million or $0.28 per share. Non-cash operating expenses for the second quarter ended June 30, 2021 were $30 million compared to $18 million for the second quarter of 2020.

Our cash used in operations for the six months ended June 30, 2021 was $98 million with a net loss of $138 million or $0.65 per share compared to cash used in operations of $72 million and a net loss for the same period in 2020 of $94 million or $0.59 per share.

We recognized revenue of $22 million and $42 million for the six-months ended June 30, 2021 and 2020, respectively, which includes revenue related to non-cash royalties earned, revenue recognized under our collaboration agreements, and in 2020, $14 million from an upfront license fee received.

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

On August 9, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher") reported that it has priced an offering of $3.1 billion aggregate principal amount (the "Offering") of the following notes (Press release, Thermo Fisher Scientific, AUG 9, 2021, View Source [SID1234586157]):

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$700 million aggregate principal amount of its 1.750% senior notes due 2028, at the issue price of 99.952% of their principal amount,
$1.2 billion aggregate principal amount of its 2.000% senior notes due 2031, at the issue price of 98.827% of their principal amount, and
$1.2 billion aggregate principal amount of its 2.800% senior notes due 2041, at the issue price of 99.508% of their principal amount.
The Offering is expected to close on or about August 23, 2021, subject to customary closing conditions. The notes will pay interest on a semi-annual basis.

Thermo Fisher intends to use the net proceeds of the Offering to pay a portion of the cash consideration payable for the pending acquisition of PPD, Inc., a Delaware corporation.

The joint book-running managers for the Offering are Barclays Capital Inc., Morgan Stanley & Co. LLC, BofA Securities, Inc. and Citigroup Global Markets Inc.

The Offering is being made pursuant to an effective registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "SEC"). Prospective investors should read the prospectus forming a part of that registration statement and the prospectus supplement related to the Offering and the other documents that Thermo Fisher has filed with the SEC for more complete information about Thermo Fisher and this Offering. These documents are available at no charge by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Thermo Fisher, the underwriters or any dealer participating in this offering will arrange to send you the prospectus if you request it by calling Barclays Capital Inc. toll-free at 1-888-603-5847; Morgan Stanley & Co. LLC toll-free at 1-866-718-1649; BofA Securities, Inc. toll-free at 1-800-294-1322;or Citigroup Global Markets Inc. toll-free at 1-800-831-9146.

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

On August 9, 2021 Prescient Therapeutics’ (ASX: PTX) reported that strong cash position will enable it to advance its multiple cancer programs, with work to follow on from what managing director Steven Yatomi-Clarke describes as "tremendous" FY 2021 (Press release, Prescient Therapeutics, AUG 9, 2021, View Source;utm_medium=rss&utm_campaign=after-tremendous-fy-2021-prescient-therapeutics-well-funded-to-advance-cancer-fighting-therapies [SID1234586069]).

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The company develops personalised medicinal approaches to cancer, including targeted and cellular therapies.

Its targeted therapy candidates PTX-100 and PTX-200 are designed to inhibit cancer growth and tumour survival, while OmniCAR is a universal immune receptor platform being developed for next-generation CAR-T therapies for acute myeloid leukemia, HER2-positive solid tumours including breast, ovarian and gastric cancers, and glioblastoma multiforme (brain cancer).

Prescient ended the June quarter with $16.1 million cash in the bank after spending $280,000 on research and development activities in Australia and the United States, particularly related to the development of OmniCAR and cell therapy enhancements, and the ongoing clinical studies of PTX-100 and PTX-200.

Recent accomplishments include successful results from a phase 1b trial of PTX-100, announced after 30 June, which has led to an expanded study of the drug candidate to treat T cell lymphoma, and trial and manufacturing milestones achieved in the development of the OmniCAR platform.

PTX-100 trial progress
At the end of July, Prescient reported results from the PTX-100 phase 1b basket trial in solid and hematological cancers that demonstrated the drug was very well tolerated at all dose levels.

Early clinical activity was also observed in two patients with aggressive disease, in which prior therapies had failed to stop its progression. One of the patients experienced a partial response (a reduction in cancer burden) from the therapy with no disease progression for 17 months so far, while the other patient experienced a reduction in cancerous lesions and symptomatic .

"In both cases, such patients with refractory T cell lymphoma on standard-of-care therapies would typically be expected to have disease progression within four months, highlighting the encouraging nature of these responses," Prescient reported.

Owing to these encouraging phase 1b results, the company is now progressing development of PTX-100 as a monotherapy in an expansion cohort study in relapsed and refractory T cell lymphoma.

If the expansion cohort is successful, Prescient could advance directly to a separate registration study which may only require small trials compared to typical phase three trials.

Prescient’s other targeted therapy, PTX-200 is currently undergoing a phase 1b clinical trial in patients with acute myeloid leukemia. Updates from this study is expected in coming months.

OmniCAR milestones
To expedite its OmniCAR milestones, Prescient expanded its research partnership with the world-renowned Peter MacCallum Cancer Centre during the June quarter.

The partnership will fast-track development of Prescient’s next generation CAR-T therapy using the OmniCAR platform.

also recently announced "excellent" results from independent in silico immunogenicity testing of OmniCAR’s key binding components, SpyTag and SpyCatcher.

According to the company, this is a key milestone that substantially de-risks the entire platform and is important for progressing Prescient’s in-house programs and external collaborations.

Immunogenicity testing evaluates the immune response against a new therapy. In the case of CAR-T cell therapies, high levels of immunogenicity can adversely impact CAR-T cell expansion and persistence, which can impact the overall safety and clinical response of the treatment.

OmniCAR’s binding system components SpyTag and SpyCatcher were independently tested by a US research provider with results demonstrating that both components have very low immunogenicity – on par with circulating human antibodies.

Prescient chief executive officer and managing director Steven Yatomi-Clarke said the results "could not have been better".

"It gives us confidence that if these therapies are ultimately delivered to patients, their immune systems will not impair the therapy itself."

"This is essential not only for Prescient’s three in-house OmniCAR programs, but also for potential external collaborators, who consider immunogenicity very stringently," he added.

The development followed the successful completion of manufacturing and delivery of critical components of the OmniCAR platform including cell binders for several cancer targets and lentiviral vectors used to produce CAR-T cells.

On August 9, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that it is offering to sell $200 million of its common stock and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock in an underwritten public offering. As part of this offering, BioCryst intends to grant the underwriters a 30-day option to purchase additional shares of common stock in an amount equal to up to 15% of the securities offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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J.P. Morgan, Evercore ISI and Piper Sandler are acting as joint book-running managers for the offering.

All of the shares to be sold in the offering are being sold by BioCryst, with the proceeds to be used for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for ORLADEYO; advancement of the worldwide development, manufacturing, regulatory and clinical activities for BCX9930 for complement-mediated diseases; discovery, manufacturing, development and clinical activities for other pipeline molecules in rare diseases; and capital expenditures and other general working capital needs.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 filed by BioCryst with the U.S. Securities and Exchange Commission (SEC) and only by means of a prospectus supplement and related prospectus. A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by telephone at (866) 803-9204; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.