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Bristol-Myers Squibb to Acquire IFM Therapeutics to Strengthen Oncology Pipeline Focus on Innate Immunity

On August 3, 2017 Bristol-Myers Squibb Company (NYSE:BMY) and IFM Therapeutics (IFM) reported that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders (Press release, Bristol-Myers Squibb, AUG 3, 2017, View Source [SID1234520020]).

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The acquisition will give Bristol-Myers Squibb full rights to IFM’s preclinical STING (stimulator of interferon genes) and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer, and is an example of Bristol-Myers Squibb’s continued focus on leveraging external innovation to expand and develop its portfolio of transformative medicines. IFM’s STING agonist program includes a lead asset that accelerates the company’s efforts against this target, while the NLRP3 agonist program includes a potential first-in-class pipeline candidate.

"Targeting innate immunity pathways represents a potentially differentiated approach in immuno-oncology designed to initiate and augment immune responses that may help the body’s natural defenses better recognize and attack tumors," said Thomas Lynch, Jr., M.D., executive vice president, chief scientific officer, Bristol-Myers Squibb. "The addition of STING and NLRP3 agonist programs broadens our ability to investigate additional pathways across the immune system and complements our immuno-oncology portfolio. We look forward to advancing the development of these important programs initiated by Gary Glick, his leadership team and leading academic and industry experts across immunology and oncology."

"A comprehensive body of preclinical data support the continued research of IFM’s NLRP3 and STING agonists with a goal of uncovering their potential benefit to patients, particularly those not served by currently available cancer immunotherapeutics. Based on its deep expertise and leadership positions in immunology, oncology, and immuno-oncology, Bristol-Myers Squibb is uniquely positioned to accelerate these programs and maximize their potential," said Gary D. Glick, Ph.D., CEO and co-founder of IFM Therapeutics.

"The company is delighted by the validation this deal brings to IFM’s technology, and under the stewardship of Bristol-Myers Squibb, researching the promise it holds for potentially improving the lives of patients," said Jean-François Formela, M.D., chair of the IFM board.

Under the terms of the agreement, Bristol-Myers Squibb will pay $300 million upon closing of the transaction. IFM stockholders also will be entitled to additional contingent payments of up to $1.01 billion for each of the first products from the two programs upon the achievement of certain development, regulatory and sales milestones. Also, IFM is eligible for additional contingent milestone payments for further products resulting from these programs. In connection with the acquisition, a newly formed entity will be established by the current shareholders of IFM – IFM Therapeutics LLC – and it will retain IFM’s current personnel and facilities, as well as its remaining research programs, which include an NLRP3 antagonist program focused on curbing immune responses that lead to inflammatory diseases and fibrosis. In consideration of an additional payment at closing and future investment, Bristol-Myers Squibb will be granted at closing certain rights against the newly formed entity’s NLRP3 antagonist program, including a right of first refusal.

The transaction has been approved by the boards of directors of both companies and by the stockholders of IFM.

Bristol-Myers Squibb and IFM anticipate the transaction will close during the third quarter of 2017. Closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

AMAG PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2017 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

On August 3, 2017 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the quarter ended June 30, 2017 (Press release, AMAG Pharmaceuticals, AUG 3, 2017, View Source [SID1234520016]).

Total GAAP revenue for the second quarter of 2017 increased to a record $158.4 million, 24% higher than the same period last year (and 14% higher than the first quarter of 2017). This increase was driven by sales growth across the product portfolio, particularly Makena (hydroxyprogesterone caproate injection), which grew 31%. The company reported operating income of $3.6 million in the second quarter of 2017, compared with $18.1 million in the same period last year. Non-GAAP adjusted EBITDA totaled $50.1 million in the second quarter of 2017, compared with $64.6 million in the second quarter of 2016.1

"AMAG delivered another quarter of record revenues and strong growth across our portfolio of products. That same commercial excellence is now being applied to the launch of Intrarosa, announced just last week," said William Heiden, president and chief executive officer. "We have already realized a number of significant milestones in 2017, and look forward to reaching many others in the second half of the year. The achievement of these goals is an important step on the path to building an even stronger company that develops and markets novel therapeutics to address significant unmet medical needs."

Second Quarter 2017 and Recent Business Highlights:
•
Hired and trained a new women’s health commercial team of approximately 150 people;
•
Launched Intrarosa, the first and only FDA-approved local non-estrogen product for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause;
•
Advanced bremelanotide development and regulatory activities to support the planned new drug application (NDA) submission in early 2018;
•
Received FDA acceptance for review of Makena subcutaneous auto-injector supplemental NDA (sNDA) and a PDUFA date of February 14, 2018;
•
Drove record quarterly sales of Makena to over $102 million;
•
Realized highest number of new family enrollments at Cord Blood Registry (CBR) since the fourth quarter of 2015;
•
Partner, Velo Bio, enrolled first patient in Phase 2b/3a study for the treatment of severe preeclampsia;
•
Achieved record quarterly sales of Feraheme and completed submission to FDA to broaden Feraheme’s label; and
•
Strengthened the balance sheet and ended the quarter with $399.2 million of cash and investments.

Second Quarter Ended June 30, 2017 (unaudited)
Financial Results (GAAP Basis)
Total revenues for the second quarter of 2017 were $158.4 million, compared with $127.4 million in the second quarter of 2016. Net product sales of Makena were $102.7 million in the second quarter of 2017, compared with $78.4 million in the same period last year. Sales of Feraheme and MuGard totaled $27.7 million in the second quarter of 2017, compared with $24.6 million in the second quarter of 2016. Service revenue from CBR totaled $28.0 million in the second quarter of 2017, compared with $24.4 million in the same period last year.

Costs and expenses, including costs of product sales and services, totaled $154.8 million in the second quarter of 2017, compared with $109.3 million for the same period in 2016. This increase was primarily due to (i) higher selling, general and administrative expenses of $29.1 million primarily related to commercial activities to support the launch of Intrarosa, including the addition of a new women’s health sales force, (ii) higher research and development expenses of $16.0 million, primarily due to development work performed by Palatin to support the NDA for bremelanotide, and (iii) higher cost of products sold of $10.2 million, of which $8.9 million was due to amortization expense related to the Makena intangible asset. Also recorded in the second quarter of 2017 was a charge of $5.8 million to acquired in-process research and development expense in connection with the closing of the company’s agreement with Endoceutics for the rights to Intrarosa.

The higher expenses in the second quarter of 2017 resulted in $3.6 million in operating income in the second quarter of 2017, a decrease of $14.4 million, as compared to $18.1 million in operating income for the same period last year. The company reported a net loss of $14.1 million, or $(0.40) per basic and diluted share, for the second quarter of 2017, compared with a net loss of $0.6 million, or $(0.02) per basic share and diluted share, for the same period in 2016. The increased net loss in the second quarter of 2017 includes a $9.5 million loss on the extinguishment of debt in connection with the early retirement of the company’s term loan and a portion of the convertible notes due in 2019.

Financial Results (Non-GAAP Basis)1
Non-GAAP revenue totaled $159.8 million in the second quarter of 2017, up from $132.5 million in the second quarter of 2016. Non-GAAP CBR service revenue totaled $29.4 million in each of the second quarters of 2017 and 2016. The difference between GAAP and non-GAAP revenue represents CBR purchase accounting adjustments related to deferred revenue.

Total costs and expenses on a non-GAAP basis totaled $109.7 million in the second quarter of 2017, compared with $67.8 million in the second quarter of 2016.

Non-GAAP adjusted EBITDA for the second quarter of 2017 was $50.1 million, resulting in an adjusted EBITDA margin of 31%. This compares to non-GAAP adjusted EBITDA of $64.6 million in the second quarter of 2016, with an adjusted EBITDA margin of 49%. The decline in adjusted EBITDA for the second quarter of 2017 is in line with the company’s expectations and stated plans to invest in the continued development of its current and future products in order to create long-term value.

Balance Sheet Highlights
As of June 30, 2017, the company’s cash and investments totaled $399.2 million and total debt (principal amount outstanding) was $861.1 million.

During the second quarter of 2017, the company issued $320 million of convertible senior notes due in 2022. The company also repurchased $158.9 million of its existing convertible senior notes due in 2019 for an aggregate purchase price of $171.3 million, including accrued interest. The company used proceeds from the convertible transactions, along with balance sheet cash, to repay the remaining balance of $321.8 million of its term loan, which was due in 2021.

"By extending our maturities and reducing our total debt by approximately $170 million, we have more financial flexibility to invest in our newest products — Intrarosa and bremelanotide, as well as continue to expand our

2

product portfolio through potential acquisitions and licensing transactions," stated Ted Myles, chief financial officer. "We are pleased with the strong second quarter and year-to-date 2017 financial performance reported today, and we are reaffirming our full year guidance."

Reaffirming 2017 Financial Guidance

2017 GAAP Guidance

2017 Non-GAAP Guidance
$ in millions

Makena sales

$410 – $440

$410 – $440
Feraheme and MuGard sales

$100 – $110

$100 – $110
CBR revenue

$110 – $120

$115 – $1253
Intrarosa

$5 – $15

$5 – $15
Total revenue

$625 – $685

$630 – $690

Net loss

($62) – ($31)2

N/A
Operating income (loss)

($23) – $272

N/A
Adjusted EBITDA

N/A

$210 – $260

Kite Announces Landmark Study of Refractory Aggressive Non-Hodgkin Lymphoma (SCHOLAR-1) Outcomes Published in the Journal BLOOD

On August 3, 2017 Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, reported the publication of the first large-scale multi-institutional analysis of outcomes of patients with refractory aggressive non-Hodgkin lymphoma (NHL) in the latest electronic edition of BLOOD (Press release, Kite Pharma, AUG 3, 2017, View Source [SID1234520014]). The study, SCHOLAR-1 (Retrospective Non-Hodgkin Lymphoma Research), showed outcomes in patients with refractory aggressive NHL subtypes including diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) or primary mediastinal B-cell lymphoma (PMBCL) following treatment with currently available therapies:

Objective response rate of 26 percent
Complete response rate of 7 percent
Median overall survival of 6.3 months
These findings highlight the unmet medical need and provide an important benchmark for studies that address this refractory patient population.

"SCHOLAR-1 demonstrates the uniformly poor treatment outcomes for patients with aggressive non-Hodgkin lymphoma and emphasizes the need for breakthrough therapies for these refractory patients," said Christian Gisselbrecht, MD, Professor of Hematology, Saint Louis Hospital at Diderot University Paris 7, and corresponding author of the study. "Although 60 to 70 percent of non-Hodgkin lymphoma patients survive five years after rituximab-based chemotherapy and autologous stem cell transplant, nearly half of them either do not respond or relapse shortly after transplant. SCHOLAR-1 provides a rigorous measure of outcomes for these patients who do not benefit from currently available therapies, and this landmark study will serve as an important historical control for evaluating new therapeutic candidates in the field of non-Hodgkin lymphoma."

Key points and findings:

SCHOLAR-1 uses pooled, patient-level data from two of the largest randomized controlled studies in NHL, the Canadian Cancer Trials Group study Ly.12 and the Lymphoma Academic Research Organization (LYSARC) Collaborative Trial in Relapsed Aggressive Lymphoma (CORAL) study, and from two observational cohorts from MD Anderson Cancer Center and the Molecular Epidemiology Resource of the University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence (IA/MC).
The analysis includes 636 patients who met criteria for refractory DLBCL, TFL and PMBCL. Refractory status was defined as progressive disease or stable disease as best response to last chemotherapy, or relapse ≤12 months post-ASCT.
While patients with relapsed/refractory NHL, a more broadly defined patient population studied in Ly.12 and CORAL, have heterogeneous outcomes to subsequent therapy, the subgroup of patients with strictly refractory NHL, as studied in SCHOLAR-1, have uniformly poor outcomes and greater unmet need.
In the refractory NHL patient pool studied in SCHOLAR-1, objective response rate was 26 percent, complete response rate was 7 percent, and median overall survival was 6.3 months.
Outcomes for the refractory NHL patient pool studied in SCHOLAR-1 were consistently poor across patient subgroups.
SCHOLAR-1 was funded through an unrestricted grant from Kite.

Agenus Reports Second Quarter 2017 Financial Results and Provides Corporate Update

On August 3, 2017 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, provided a corporate update and reported financial results for the second quarter ended June 30, 2017 (Press release, Agenus, AUG 3, 2017, View Source [SID1234520012]).

"In the second quarter, we advanced our anti-CTLA-4 and anti-PD-1 antibodies in preparation for initiating combination trials in the second half of this year. We also produced GMP grade product in our facilities in Berkeley and selected a commercial supplier for our lead antibodies. In addition, our partnering efforts are maturing and we expect to close on several transactions in the second half of this year," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We are committed to our path of generating potential first-in-class and best-in-class immuno-oncology agents, and doing so with speed, quality and efficiency."

Anticipated Milestones for H2 2017:

AGEN1884 (anti-CTLA-4) Phase 1 trial: complete dose-escalation and compile safety and pharmacodynamic data
AGEN2034 (anti-PD-1) Phase 1/2 trial:
Complete dose-escalation for monotherapy, define optimal combination dose and collect safety and receptor occupancy data
Recruit patients with second line cervical cancer
AGEN1884+AGEN2034 Phase 1b trial: commence combination trial
AutoSynVax (neoantigen vaccine): immunological readouts expected in patients with advanced malignancies
Advance our cell therapy spin off efforts
Secure substantial funds from existing agreements and future transactions
Recent Highlights:

AGEN1884 interim data presented at ASCO (Free ASCO Whitepaper):
Safe at doses up to 3 mg/kg
Partial response in a patient with angiosarcoma with 92% reduction in tumor burden at 0.1 mg/kg dose (since ASCO (Free ASCO Whitepaper) this patient has experienced a complete response)
QS-21 Stimulon update:
GSK’s shingles vaccine containing Agenus’ QS-21 Stimulon adjuvant showed strong immunogenicity in patients previously treated with standard of care (Merck’s Zostavax)
U.S. regulatory approval of Shingrix is anticipated in Q4
Manufacturing readiness:
Agenus West successful GMP production of AGEN2034 at 1,000L scale
Selection of CMOs for production of commercial grade material for planned registrational trials
Second Quarter 2017 Financial Results

Cash, cash equivalents and short-term investments were $96.8 million at June 30, 2017 compared to $76.4 million as of December 31, 2016.

For the six months ended June 30, 2017, Agenus reported a net loss of $48.8 million, or $0.51 per share, compared with a net loss for the same period in 2016 of $60.1 million or $0.69 per share. The decrease in net loss for the six months ended June 30, 2017, compared to the net loss for the same period in 2016, was primarily due to the accelerated milestone payment received from Incyte during the first quarter of 2017. Our operating expenses increased $9.2 million over the same period in 2016.

For the second quarter ended June 30, 2017, Agenus reported a net loss of $31.7 million, or $0.32 per share, compared with a net loss for the second quarter of 2016 of $28.3 million, or $0.33 per share. The increase in net loss for the three months ended June 30, 2017, compared to the net loss for the same period in 2016, was primarily due to the later stage advancement of our programs.

Adaptimmune Reports Second Quarter 2017 Financial Results

On August 3, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported financial results and business updates for the quarter ended June 30, 2017 (Press release, Adaptimmune, AUG 3, 2017, View Source [SID1234520011]).

"This was a very exciting quarter for Adaptimmune," commented James Noble, Adaptimmune’s Chief Executive Officer. "We made significant progress clinically by initiating our first trials with two proprietary programs, MAGE-A4 and AFP, and also initiated our first combination study with NY‑ESO. We presented data in an oral presentation at ASCO (Free ASCO Whitepaper), showing responses in all four cohorts in our NY-ESO synovial sarcoma study. And, importantly, we also extended our cash runway to late 2019, well past the expected data points on all three of our proprietary programs. We are now focused on delivering clinical data across multiple tumor types as we move through the second half of this year and into 2018. We are also very encouraged by FDA’s Oncology Drug Advisory Committee’s recent unanimous endorsement of Novartis’s anti-CD19 CAR-T therapy, with which we share common manufacturing process elements, as this is a positive review of the first gene therapy cell product in the US."

Recent Corporate Highlights:

Completed April 2017 registered direct offering to Matrix Capital Management Company, LP, which combined with March 2017 public offering, raised total net proceeds of $103.2 million;
Initiated AFP SPEAR T-cell therapy clinical trial in hepatocellular carcinoma;
Initiated MAGE-A4 SPEAR T-cell therapy clinical trial in urothelial (bladder), melanoma, head & neck, ovarian, non-small cell lung cancer (NSCLC), esophageal, and gastric cancers;
Initiated clinical trial of NY-ESO SPEAR T‑cells in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 inhibitor marketed by Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), in patients with multiple myeloma;
Presented data during an oral presentation at ASCO (Free ASCO Whitepaper) from ongoing study of NY-ESO SPEAR T-cells in synovial sarcoma indicating that:
Initial anti-tumor activity observed in all ongoing cohorts including low expressors of NY‑ESO
Fludarabine appears to be an important component of the lymphodepletion regimen
NY-ESO continues to be generally well-tolerated:
All reported events of cytokine release syndrome resolved, and the majority of events were Grade 1 or 2
There were no reported events of seizure, cerebral edema, or encephalopathy
Survival and response data in Cohort 1 (non-modified fludarabine / cyclophosphamide ["Flu/Cy"] lymphodepletion regimen) continue to be promising (data cutoff March 30, 2017):
Of the 12 patients treated, 5 remain alive with a median predicted overall survival of 120 weeks (~28 months), and 6 responses were observed
10 patients received the target dose of 1 billion transduced NY‑ESO SPEAR T-cells, and the median predicted overall survival for those patients is 159 weeks (~37 months)
Financial Results for the Three Months ended June 30, 2017

Cash / liquidity position: As of June 30, 2017, Adaptimmune had cash and cash equivalents of $122.0 million and Total Liquidity1 of $220.0 million.
Revenue: Revenue represents the upfront and milestone payments, which are recognized over the period the Company delivers services to GSK. Revenue for the three months ended June 30, 2017 was $3.5 million. The increase in revenue is due to the revenue in the three months ended June 30, 2016 being adversely impacted by a change in estimate of the period over which revenue is being recognized, which reduced revenue in that quarter by $2.8 million.
Research and development ("R&D") expenses: R&D expenses for the three months ended June 30, 2017 were $19.6 million, compared to $16.9 million for the same period of 2016. The increase was primarily due to increased costs associated with clinical trials; costs of developing manufacturing capability in the Company’s U.S. facility and increased personnel expenses.
General and administrative ("G&A") expenses: G&A expenses for the three months ended June 30, 2017 were $7.7 million, compared to $6.2 million for the same period of 2016. The increase was primarily due to increased personnel costs consistent with our planned growth.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three months ended June 30, 2017 was $20.2 million ($(0.04) per ordinary share or $(0.24) per American Depositary Share ("ADS") compared to $22.1 million ($(0.05) per ordinary share or $(0.31) per ADS) in the same period of 2016.
Financial Guidance
The Company believes that its existing cash and cash equivalents, short-term deposits and marketable securities will fund the Company’s current operating plan through to late 2019.

1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.