BPC July 27 update

Infinity INFI -32% Phase 2 trial data; ObsEva OBSV +14% license deal

Price and Volume Movers

Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) announced data from MARIO-275, its Phase 2 trial of eganelisib in combination with nivolumab (Opdivo) in patients with urothelial cancer as well as data from MARIO-3, its Phase 2 trial evaluating eganelisib in combination with atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) in patients with Triple Negative Breast Cancer (TNBC). Patients in the MARIO-3 trial showed a partial response rate of 55.3% which included two complete and 19 partial responses from 38 patients, which were lower than expectations. Median overall survival data from the MARIO-275 trial was 15.4 months compared to 7.9 months in the control arm. The stock closed down 32% with a price of $1.52.

Sol-Gel Technologies, Ltd. (NASDAQ:SLGL) announced that the FDA approved TWYNEO for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. After opening up 16% higher, shares sold off during the day to close flat with a price of $12.00.

Repligen Corporation (NASDAQ:RGEN) reported revenue of $163.0 million for the quarter, representing year-over-year growth of 86% and organic growth of 69%. In addition, revenue guidance was raised to $625-$645 million for the full year 2021 and adjusted (non-GAAP) fully diluted EPS is expected to be in the range of $2.71-$2.78, an increase from their previous guidance of $2.21-$2.28. Shares rose 10% on the day to $226.38.

ObsEva (NASDAQ:OBSV) and Organon (NYSE:OGN) announced a license deal whereby Organon will license rights to ebopiprant (OBE022). Organon will gain exclusive worldwide rights to develop and commercialize ebopiprant. ObsEva receives $25 million upfront and $475 million in potential milestone payments and tiered double-digit royalties on commercial sales. Shares closed up 14% to $2.87.

EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) announced yesterday that Brian M Strem, Ph.D., Co-Founder, Director and former Chief Executive Officer of Okogen, Inc as well as Co-Founder and Managing Director of Bayon Therapeutics, was appointed as permanent President, Chief Executive Officer and board member, effective immediately. Additionally, EyeGate has entered a non-binding letter of intent (the "LOI") to acquire Bayon Therapeutics. Shares closed up 21% on the day with a price of $3.77.

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Other major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

BiondVax Pharmaceuticals Ltd. (BVXV): $3.44; +27%

NanoViricides, Inc. (NNVC): $4.92; +17%

Sonnet BioTherapeutics Holdings, Inc. (SONN): $1.12; +9%

Lava Therapeutics B.V. (LVTX): $7.62; +6%

Cyteir Therapeutics, Inc. (CYT): $16.64; +8%

DECLINERS:

Adagene Inc. (ADAG): $13.70; -19%

Oramed Pharmaceuticals Inc. (ORMP): $13.42; -16%

180 Life Sciences Corp. (ATNF): $7.08; -16%

Candel Therapeutics, Inc. Common Stock (CADL): $7.00; -13%

Acumen Pharmaceuticals, Inc. (ABOS): $14.50; -12%

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ARNA – Arena Pharmaceuticals Inc.
RIST4721
Palmoplantar Pustulosis

$61.05
+1.10  +2%
Phase 2b Phase 2b trial to be initiated.
$3.7 billion

ETTX – Entasis Therapeutics Holdings Inc.
SUL-DUR (ATTACK)
Acinetobacter baumannii infections

$3.11
+0.20  +7%
Phase 3 Phase 3 top-line data due early-4Q 2021.
$147.1 million

INFI – Infinity Pharmaceuticals Inc.
Eganelisib (IPI-549) + OPDIVO (nivolumab) - (MARIO-275)
Urothelial cancer

$3.63
+0.21  +6%
Phase 2 Phase 2 update July 27, 2021. Median overall survival 15.4 months compared to 7.9 months on nivolumab control arm. Program update due by end of 2021.
$322.1 million

INFI – Infinity Pharmaceuticals Inc.
Eganelisib (IPI-549) + TECENTRIQ (atezolizumab) and ABRAXANE (nab-paclitaxel) and IPI-549 + TECENTRIQ (atezolizumab) and AVASTIN (Bevacizumab) - (MARIO-3)
Front-line triple negative breast cancer (TNBC); Renal cell cancer (RCC)

$3.63
+0.21  +6%
Phase 2 Phase 2 updated data released July 27, 2021. Overall response rate 55% in patients. PFS was extended as compared to benchmark data for atezolizumab and nab-paclitaxel alone, increasing from 7.2 months to 7.4 months.
$322.1 million

MDNA – Medicenna Therapeutics Corp.
MDNA11 (ABILITY)
Solid tumors

$2.50
+0.09  +4%
Phase 1/2 Phase 1/2 trial to be initiated 3Q 2021 with top-line safety, PK/PD and biomarker data due end of 2021 and initial efficacy data in 2022.
$134.4 million

MRK – Merck & Company Inc.
KEYTRUDA (pembrolizumab) - (KEYNOTE-522)
Triple negative breast cancer (TNBC)

$71.68
-0.29  -0%
Approved FDA approval announced July 27, 2021.
$181.4 billion

RDUS – Radius Health Inc.
TYMLOS (Abaloparatide) -SC ATOM
Male Osteoporosis

$12.80
+0.62  +5%
Phase 3 Phase 3 data due 2H 2021.
$605 million

RDUS – Radius Health Inc.
TYMLOS (Abaloparatide) -Transdermal Patch (wearABLe)
Osteoporosis

$12.80
+0.62  +5%
Phase 3 Phase 3 data due 2H 2021.
$605 million

RLMD – Relmada Therapeutics Inc.
REL-1017 (RELIANCE I)
Treatment Resistant Depression

$27.56
+0.45  +2%
Phase 3 Phase 3 data due 1H 2022. Human abuse trial vs Oxycodone confirmed lack of opioid abuse potential.
$481.6 million

SLGL – Sol-Gel Technologies Ltd.
Twyneo
Acne

$9.47
-0.37  -4%
Approved FDA approval announced July 27, 2021.
$218.1 million

VSTM – Verastem Inc.
VS-6766 and Defactinib - FRAME
KRAS mutant advanced solid tumors

$2.76
+0.06  +2%
Phase 1/2 Phase 1/2 updated data due at ESMO September 19, 2021.
$498.9 million

VSTM – Verastem Inc.
VS-6766 and defactinib (RAMP 201)
Low-grade serous ovarian cancer (LGSOC)

$2.76
+0.06  +2%
Phase 2 Phase 2 selection phase top-line data due 1H 2022.
$498.9 million