On May 3, 2023 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that it intends to offer and sell, subject to market and other conditions, $200 million of shares of its common stock in an underwritten public offering (Press release, ImmunoGen, MAY 3, 2023, View Source [SID1234630924]). ImmunoGen also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the number of shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions. All of the shares of common stock to be sold in the offering are to be offered by ImmunoGen. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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ImmunoGen intends to use the net proceeds from this offering to fund its operations, including, but not limited to, global commercialization activities, supply of ELAHERE (mirvetuximab soravtansine-gynx) drug product, clinical trial activities, pipeline research and development activities, business development activities, and capital expenditures.

Jefferies, Goldman Sachs & Co. LLC, and Guggenheim Securities are acting as joint book-running managers for the proposed offering.

The securities described above are being offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by phone at (866) 471-2526, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by email at [email protected] or by telephone at (212) 518-9544.

On May 3, 2023 Immunocore Holdings Plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, reported that management will present at the Bank of America Securities 2023 Health Care Conference (Press release, Immunocore, MAY 3, 2023, View Source [SID1234630923]).

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The fireside chat is scheduled for Wednesday, May 10, 2023, at 5:00 p.m. Pacific Daylight Time (PDT).

The fireside chat will be webcast live and can be accessed in the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentation will be made available for a limited time.

On May 3, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported positive early interim clinical trial data: 100% Tumor Shrinkage at 2-months in advanced metastatic colorectal cancer demonstrated by IMX-110 + BeiGene / Novartis anti-PD-1 antibody tislelizumab combination in the first cohort of patients (two out of two first evaluable patients) who received the lowest IMX-110 dose in its ongoing dose escalation 1b/2a clinical trial of IMX-110 + anti-PD-1 antibody tislelizumab (IMMINENT-01), as of the April 14, 2023 data cutoff date (Press release, Immix Biopharma, MAY 3, 2023, View Source [SID1234630920]).

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"We are excited to see 100% tumor shrinkage in the very first cohort at the lowest dose of IMX-110 in combination with anti-PD-1 antibody tislelizumab in our ongoing IMMINENT-01 dose escalation trial, especially in patients with advanced colorectal cancer, who have limited treatment options," said Ilya Rachman, MD PhD, CEO of ImmixBio. "These initial results potentially validate the scientific rationale for the promise of IMX-110 to unlock our immune system’s ability to fight cancer."

Dosing of the first cohort of three advanced metastatic colorectal cancer patients is complete, as of April 14, 2023, for the ongoing Phase 1b portion of the IMMINENT-01 Phase 1b/2a clinical trial investigating IMX-110 in combination with BeiGene / Novartis anti-PD-1 antibody tislelizumab in advanced solid tumors, including colorectal cancer. No dose limiting toxicities have been observed in the first cohort, which means that the trial can now enroll the next cohort of three patients at a higher dose of IMX-110 in combination with anti-PD-1 antibody tislelizumab. Tumor shrinkage was observed in the first two out of two (2/2) evaluable patients (100%) at 2-months. To put this early interim clinical data in perspective, anti-PD-1 antibody pembrolizumab alone (marketed as KEYTRUDA by Merck) produced tumor shrinkage in 3 of 19 patients (16%) with an evaluable postbaseline tumor assessment in a Phase 1b study of pembrolizumab in patients with advanced or metastatic colorectal cancer according to O’Neil, et al., 2017. This study was not a head-to-head evaluation with IMX-110 and differences exist between trial designs, subject characteristics, and caution should be exercised when evaluating clinical data across studies.

The PD-1/PD-L1 antibody market size is approximately $49.5 billion in 2023 and expected to reach $123.3 billion by 2033 according to Future Market Insights.

The colorectal cancer market is estimated to reach approximately $31.2 billion by 2025 from the estimated $26.3 billion in 2019 according to IndustryARC.

About IMMINENT-01
IMMINENT-01 is a first-of-its-kind, ongoing phase 1b/2a clinical trial combining tissue specific therapeutic IMX-110 with BeiGene / Novartis’ anti-PD-1 antibody tislelizumab, in patients with advanced solid tumors. The novel approach combining TSTx IMX-110 with anti-PD-1 antibody tislelizumab is designed to expand the population of cancer patients experiencing extended remissions from immunotherapies by converting immunologically "cold" tumors "hot".

In Phase 1b of IMMINENT-01, cohorts of 3 patients will receive escalating doses of IMX-110 until the maximum tolerated dose is reached and the recommended phase 2 dose is determined.

Phase 2a will then begin, treating patients in certain solid tumor indications selected based on Phase 1b clinical data collected in a variety of tumor types. 30 patients are expected to be enrolled in IMMINENT-01.

The primary endpoints of IMMINENT-01 are to identify the maximum tolerated dose and recommended Phase 2 dose of IMX-110 + anti-PD-1 antibody tislelizumab, and to evaluate safety. The secondary endpoints of IMMINENT-01 are to evaluate the pharmacokinetics and preliminary efficacy of IMX-110 + anti-PD-1 antibody tislelizumab.

As of the data cutoff of April 14 2023, the first cohort dosing at the lowest dose of IMX-110 + anti-PD-1 antibody tislelizumab has reached full enrollment.

Immix Biopharma is currently enrolling the next higher dose cohort of IMX-110 + anti-PD-1 antibody tislelizumab in advanced solid tumors.

About Colorectal Cancer

According to American Cancer Society, there were roughly 153,020 new cases of colorectal cancer in the United States in 2023. Globally, there are roughly 1,930,000 new cases of colorectal cancer each year, of which 519,500 are in Europe, 148,500 are in Japan, 20,500 are in Australia and New Zealand, and 555,000 are in China. The five-year survival rate in the United States for advanced metastatic CRC is 15.6% according to NIH SEER.

On May 3, 2023 Horizon Therapeutics plc (Nasdaq: HZNP) reported first-quarter 2023 financial results (Press release, Horizon Pharma, MAY 3, 2023, View Source [SID1234630919]).

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"We generated strong first-quarter performance, with double-digit growth for KRYSTEXXA and UPLIZNA, and saw positive trends in TEPEZZA’s leading indicators as we exited the first quarter," said Tim Walbert, chairman, president and chief executive officer, Horizon. "Importantly, we announced positive topline results from our TEPEZZA clinical trial in low CAS and long-duration TED patients, as well as received FDA approval for an update to the TEPEZZA indication that reinforces the potential benefit of TEPEZZA, regardless of disease activity or duration. These important events will help us to ease the access burden so all eligible patients can benefit from TEPEZZA. I am extremely proud of what we have accomplished in a few short months and believe we are well positioned as we prepare to become part of Amgen."

Financial Highlights

(in millions except for per share amounts and percentages) Q1 23 Q1 22 %
Change
Net sales

$ 832.1 $ 885.2 (6 )
Net income

54.7 204.3 (73 )
Non-GAAP net income

194.3 315.8 (38 )
Adjusted EBITDA

232.9 371.2 (37 )
Earnings per share – diluted

0.23 0.87 (74 )
Non-GAAP earnings per share – diluted

0.83 1.34 (38 )
First-Quarter 2023 Net Sales Results

(in millions except for percentages) Q1 23 Q1 22 % Change
TEPEZZA

$ 405.3 $ 501.5 (19 )
KRYSTEXXA

187.0 140.7 33
RAVICTI

90.3 78.3 15
UPLIZNA(1)

53.8 30.5 77
PROCYSBI

50.5 49.6 2
ACTIMMUNE

29.1 31.3 (7 )
PENNSAID 2%(2)

9.2 35.4 (74 )
RAYOS

5.0 13.5 (63 )
BUPHENYL

1.4 2.2 (35 )
QUINSAIRTM

0.3 0.3 0
DUEXIS

0.1 1.1 (88 )
VIMOVO

0.1 0.9 (99 )

Total Net Sales

$ 832.1 $ 885.2 (6 )

(1)
First-quarter 2023 UPLIZNA net sales included $6.6 million in international net sales related primarily to revenue and milestone payments from the Company’s international partners. First-quarter 2022 UPLIZNA net sales included $5.2 million in international net sales.

(2)
On May 6, 2022, Apotex Inc. initiated an at-risk launch of generic PENNSAID 2% in the United States.

Key Growth Drivers

TEPEZZA: TEPEZZA net sales in the first quarter were $405 million, representing an 18 percent sequential decline compared to the fourth quarter of 2022. Net sales were impacted by seasonality, which the Company typically sees with its infused medicines in the first quarter each year. In addition, the TEPEZZA field-force expansion initiated late in 2022 has not yet substantially impacted net sales. More recently, the Company has seen the expansion drive positive momentum in the business, including increases in new prescribers, patient enrollment forms and patient starts. As new prescribers and patients work through the reimbursement process, the Company expects a more meaningful impact to net sales later in the year.

In April 2023, the Company announced positive topline results from its TEPEZZA Phase 4 clinical trial in patients with low CAS and long-duration TED and received FDA approval for an update to the indication for TEPEZZA that supports its potential benefit in TED, regardless of disease activity or duration. This reinforces the importance of unrestricted access for eligible patients across the full spectrum of TED and creates an opportunity to ease the access burden for patients and physicians and to decrease time to therapy for patients who may benefit from TEPEZZA. The Company plans to present data from the Phase 4 trial at a future medical congress and publish the data in a peer-reviewed medical journal to help educate key stakeholders, including physicians, patients and payors.

KRYSTEXXA: KRYSTEXXA first-quarter net sales were $187 million, representing a year-over-year increase of 33%. Sequentially, net sales declined by 13 percent compared to fourth-quarter 2022 due to seasonality. Strong performance in the first quarter was driven by the continued momentum in both the rheumatology and nephrology market segments, including the adoption of KRYSTEXXA with immunomodulation as the new standard of care following FDA approval in July 2022 for an expanded label to include KRYSTEXXA with methotrexate. The Company’s efforts to educate physicians and key stakeholders continues to lead to strong patient growth from both new and existing prescribers across both market segments.

UPLIZNA: UPLIZNA first-quarter 2023 net sales were $53.8 million, representing a year-over-year increase of 77%, driven by continued strong execution. Net sales in the U.S. were $47.2 million, an increase of 87%, and were driven by strong and consistent growth in new prescribers and new patient starts. The Company continues to advance its global expansion strategy with multiple planned international launches in 2023.

Conference Call

In light of the announced agreement to be acquired by Amgen Inc. and applicable securities laws, the Company will not be hosting a conference call to discuss its financial results. This earnings press release and the related Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 are publicly available in the Investor Relations section of the Company’s website at View Source

On May 3, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported it will present its first quarter 2023 financial results and provide a corporate update following market close on Thursday, May 11, 2023 (Press release, Gritstone Bio, MAY 3, 2023, View Source [SID1234630917]). The announcement will be followed by a conference call and audio webcast, which will begin at 4:30pm ET.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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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Live Conference Call & Webcast
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Conference ID: 1754341
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While not required, it is recommended you join five minutes prior to the event’s start. An archived replay will be accessible at View Source for 30 days following the event.